Diabetes Mellitus, Type 2
Conditions
Brief summary
The primary purpose of this study is to determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a single dose and multiple administrations in type 2 diabetic subjects. The secondary purpose of this study is to determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.
Detailed description
Study Objectives Primary: 1. To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive days. 2. To characterize the pharmacokinetic profile of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) after a single dose and multiple administrations in type 2 diabetic subjects. Secondary: 1\. To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects. Study Design: Prospective, multi-center, clinical study of SRT2104 administered orally once daily for 28 consecutive days; randomized, placebo-controlled, double-blind, multiple-dose, inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in type 2 diabetic male and female subjects on an existing, stable, background metformin therapy. Approximately 225 subjects aged 30-70, who fulfill the inclusion/exclusion criteria, will be enrolled in this study to ensure completion of forty (40) evaluable subjects within each of five dosing groups. Subjects will be evenly randomized to receive SRT2104 at one of five doses, placebo (A), 0.25 g/day (B), 0.5 g/day (C), 1.0 g/day (D), or 2.0 g/day (E), once a day for 28 consecutive days, approximately 15 minutes following consumption of a standardized meal. Subjects will remain on a fixed dose of test material for all dosing days in the study. Subjects will sign the informed consent form at the Screening Visit, and will undergo screening assessments over a 2-day period to verify eligibility for the study. If eligible and willing to participate, subjects will return to the clinic within 21 days of the Screening Visit to participate in the dosing phase of the study. Subjects will be randomized to receive SRT2104 or placebo, and will be required to stay overnight at the study center on Day -1 and Day 27 to gather required PK samples and to assess safety on Day 1 and Day 28 respectively. In addition, subjects will be asked to return to the study center on Days 2 and 29; for three interim weekly safety assessments (on Days 8, 15, 22); and for an End of Study safety assessment 7 days after they complete the 28-day dosing period. A follow-up safety call will be made to each subject 30 days following their final dose of SRT2104 or placebo.
Interventions
DRUGSRT2104
SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg.
DRUGPlacebo
Placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
Sponsors
GlaxoSmithKline
Sirtris, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects of any race and gender within the age range of 30 to 70 years. 2. All female subjects must be of non-child-bearing potential. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or women who underwent tubal ligation. Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 - 138 mIU/ml and oestradiol \< 20 pg/ml at entry, unless this information is available in the subject's medical record. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor and medical monitor 3. All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug. 4. Willingness to provide written informed consent to participate in the study 5. HbA1c ≥ 7.5 and ≤ 10.5 6. Fasting glucose ≥ 160 and ≤ 240 mg/dL 7. Body Mass Index (BMI) ≥ 25.0 kg/m\^2 and ≤ 40.0 kg/m\^2 8. On stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to Screening 9. No prior history of HIV 1 or 2 10. Absence of disease markers for hepatitis B & C virus 11. Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening; normal end organ function 12. Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant 13. Have a normal chest X-ray (P. A. View) or one with abnormality considered to be clinically insignificant 14. Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol
Exclusion criteria
1. Any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes 2. Renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dL for females and ≥ 1.5 mg/dL for males, and greater than two times the upper limit of normal for liver enzymes, respectively. 3. History of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy 4. History, within 3 years, of drug abuse (including Benzodiazepines, opioids, amphetamine, cocaine, and THC) 5. History of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hrs prior to dosing \[one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)\] 6. Participation in any clinical trial within the past three months 7. History of difficulty in donating blood or accessibility of veins in left or right arm 8. Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material 9. Use of any prescription drug therapy, with exception of any prescription medication administered at a stable dose for at least 6 weeks prior to Screening, provided the medication is not contraindicated by the metformin label 10. Use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose) | Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. |
| Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Baseline (Day 1) and up to Day 35 | Assessment for mean corpuscular volume was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | Baseline (Day 1), Day 28 and Day 35 | Assessment for aPTT and PT were performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values. |
| Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Baseline (Day 1), Day 28 and Day 35 | Assessment for international normalized ratio was performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values. |
| Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Baseline (Day 1) and up to Day 35 | Assessment for ALT, AST, ALP, creatinine phosphokinase and LDH were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Baseline (Day 1) and up to Day 35 | Assessment for bicarbonate, BUN, calcium, chloride, magnesium, phosphate, potassium and sodium were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Baseline (Day 1) and up to Day 35 | Assessment for direct bilirubin, indirect bilirubin, serum creatinine, total bilirubin and uric acid were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Baseline (Day 1) and up to Day 35 | Assessment for lipid profile was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. The parameters included high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and triglycerides. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Baseline (Day 1) and up to Day 35 | Assessment for albumin and total protein were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Baseline (Day 1) and up to Day 35 | Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Urinalysis Parameter of pH Over Time | Baseline (Day 1) and up to Day 35 | Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessment was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28) | The pre-dose blood samples were collected within one hour prior to study medication administration. The post-dose blood samples were collected within 2 minutes of the scheduled time. AUC values reported in the analysis of AUC 0-infinity of Day 28 versus Day 1 included AUC 0-infinity on Day 1 and AUC 0-τ on Day 28. Participants fasted for at least 10 hour overnight on Day 1, 2 and 29. The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC0-infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log10 transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts. |
| Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose) | Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. On Day 1, Day 2 and Day 29, participants fasted for at least 10 hour overnight. The post-dose sample was collected within 2 minutes of the scheduled time. The first occurrence of the Cmax was determined directly from the raw concentration-time data. |
| Time to Cmax (Tmax) at Day 1 and Day 28 | Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose) | Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. The time at which Cmax was observed was determined directly from the raw concentration-time data. |
| Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose) | Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. The t1/2 was obtained as the ratio of ln2/λz, where λz is the terminal phase rate constant estimated by linear regression analysis of the concentration-time data. |
| Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose) | Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. |
| Number of Participants With AE by Intensity of Mild, Moderate and Severe | Up to Follow-up (58 days) | Intensity for each AE was categorized as mild, moderate and severe. Mild was defined as awareness of sign or symptom, but easily tolerated; moderate was defined as discomfort enough to cause interference with normal daily activities; severe was defined as inability to perform normal daily activities. |
| Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Up to Follow-up (58 days) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. AE's were classified as related to the study medication, based on the investigator's judgment. |
| Mean Change From Baseline in Weight Over Time | Baseline (Day 1) and up to Day 35 | Participant's body weight was assessed in the beginning of the study (at Day 1) and at the end of the study (Day 28 and Day 35). The clinical staff was instructed to use calibrated scales for weight measurement. The same scale was used at the clinical site for all participants at each specified time point during the study. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values. |
| Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | Baseline (Day 1, pre-dose) and up to Day 35 | Vital sign assessment of SBP and DBP was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values. |
| Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Baseline (Day 1, pre-dose) and up to Day 35 | Vital sign assessment of HR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values. |
| Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Baseline (Day 1, pre-dose) and up to Day 35 | Vital sign assessment of RR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values. |
| Change From Baseline in Vital Sign Parameter of Temperature Over Time | Baseline (Day 1, pre-dose) and up to Day 35 | Vital sign assessment of temperature was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values. |
| Change From Baseline in Electrocardiogram (ECG) Values Over Time | Baseline (Day 1, pre-dose) and up to Day 35 | 12-lead ECG was obtained in the rested state. Participants lied in supine position with ECG leads on for at least 5 minutes prior to ECG recording. The ECG was performed at Day 1 (pre-dose and post-dose), Day 8, Day 15, Day 22, Day 28 (pre-dose and pre-dose) and Day 35, and included the assessment of PR interval, QRS interval, QT interval and QTc interval. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1 \[post-dose\], Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseline (Day 1) and up to Day 35 | Assessment for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and white blood cell (WBC) count were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Baseline (Day 1) and up to Day 35 | Assessment for RBC count was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Hematology Parameter of Hematocrit Over Time | Baseline (Day 1) and up to Day 35 | Assessment for hematocrit was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Baseline (Day 1) and up to Day 35 | Assessment for hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Baseline (Day 1) and up to Day 35 | Assessment for mean corpuscular hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Baseline (Day 1) and up to Day 35 | Assessment for mean corpuscular hemoglobin concentration was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in FPG Levels Over Time | Baseline (Day 1) and up to Day 35 | The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Mean Fasting Plasma Insulin (FPI) Levels Over Time | Up to Day 35 | The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. |
| Change From Baseline in FPI Over Time | Baseline (Day 1) and up to Day 35 | The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values. |
| Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | Day 28 | The assessment of PPG and PPI was performed on Day 28 at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast). |
| Change From Baseline in PPG and PPI Levels at Day 28 | Baseline (Day 1) and Day 28 | The assessment of PPG and PPI was performed at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. Baseline for PPG was defined as the assessment value of FPG done on Day 1 and Baseline for PPI was defined as the assessment value of FPI done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (30 min, 60 min and 2 h at Day 28) values. |
| Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28 | Day 28 | The sample for HbA1c assessment was collected on Day 28. HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months. |
| Change From Baseline in HbA1c Levels at Day 28 | Baseline (Day 1) and Day 28 | HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected on Day 1 and Day 28. Baseline value was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value. |
| AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1 (30 minutes, 60 minutes and 2 hour) and Day 28 (30 minutes, 60 minutes and 2 hour) | The assessment of PPG and PPI was performed at 30 minutes, 60 minnutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. AUC with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times) for PPG and PPI. |
| Mean Fructosamine Levels at Day 1 and Day 28 | Day 1 and Day 28 | Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28. |
| Change From Baseline in Fructosamine Levels at Day 28 | Baseline (Day 1) and Day 28 | Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value. |
| Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 1 and Day 28 | HOMA-IR was derived from FPG and FPI as: FPI (micro units \[mU\]/mL)\*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. |
| Change From Baseline in HOMA-IR at Day 28 | Baseline (Day 1) and Day 28 | HOMA-IR was derived from FPG and FPI as: FPI (mU/mL)\*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value. |
| Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 1 and Day 28 | HOMA-percentage cell beta function was derived from FPG and FPI as: 20\*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. |
| Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28 | Baseline (Day 1) and Day 28 | HOMA-percentage cell beta function was derived from FPG and FPI as: 20\*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as assessment done on Day 1. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value. |
| Mean Fasting Plasma Glucose (FPG) Levels Over Time | Up to Day 35 | The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. |
Countries
Bulgaria, Estonia, Hungary, Poland, Romania, Russia, Ukraine, United Kingdom
Participant flow
Recruitment details
The study was planned on 225 male and female participants with type 2 diabetes (T2D) on an existing, stable, background metformin therapy, aged 30 to 70 years, at 45 centers of Bulgaria (7), Estonia (1), Hungary (4), Poland (4), Romania (6), Russia (13), United Kingdom (3) and Ukraine (7) from 19 August 2009 to 18 September 2010.
Pre-assignment details
Out of 527 participants screened, 227 with glycosylated hemoglobin A (HbA1c) of \>=7.5% and \<= 10.5% and a fasting glucose (FG) \>=160 and \<=240 milligram per deciliter (mg/dL) were randomized in 1:1:1:1:1 to oral dose of placebo or any one of 4 doses of SRT2104 (0.25, 0.5, 1.0 or 2.0 gram per day \[g/day\]), once a day for 28 consecutive days.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received oral dose of matching placebo to SRT2104 capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water. | 46 |
| SRT2104 0.25 g/Day Participants received oral dose of SRT2104 0.25 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water. | 45 |
| SRT2104 0.5 g/Day Participants received oral dose of SRT2104 0.5 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water. | 46 |
| SRT2104 1.0 g/Day Participants received oral dose of SRT2104 1.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water. | 45 |
| SRT2104 2.0 g/Day Participants received oral dose of SRT2104 2.0 g/day capsule, once daily for 28 consecutive days. The study medication was administered as 8 capsules per day to maintain the blinding, at the same time every morning, approximately 15-30 min following the start of meal consumption with 1 to 2 glasses of water. | 45 |
| Total | 227 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 1 | 1 | 2 |
| Overall Study | Chest X-ray showed a suspicious shadow | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 4 | 1 | 4 | 3 |
Baseline characteristics
| Characteristic | Placebo | Total | SRT2104 2.0 g/Day | SRT2104 1.0 g/Day | SRT2104 0.5 g/Day | SRT2104 0.25 g/Day |
|---|---|---|---|---|---|---|
| Age, Continuous | 55.8 Years STANDARD_DEVIATION 8.4 | 57.0 Years STANDARD_DEVIATION 8.67 | 55.9 Years STANDARD_DEVIATION 9.03 | 57.3 Years STANDARD_DEVIATION 8.95 | 57.7 Years STANDARD_DEVIATION 9 | 58.2 Years STANDARD_DEVIATION 8.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 45 Participants | 225 Participants | 44 Participants | 45 Participants | 46 Participants | 45 Participants |
| Sex: Female, Male Female | 28 Participants | 126 Participants | 18 Participants | 30 Participants | 28 Participants | 22 Participants |
| Sex: Female, Male Male | 18 Participants | 101 Participants | 27 Participants | 15 Participants | 18 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 | 1 / 44 | 0 / 42 | 0 / 43 |
| other Total, other adverse events | 7 / 43 | 4 / 43 | 12 / 44 | 5 / 42 | 8 / 43 |
| serious Total, serious adverse events | 0 / 43 | 1 / 43 | 1 / 44 | 0 / 42 | 0 / 43 |
Outcome results
Primary
Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28
Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.
Time frame: Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 1 | 494.0236 Liter/hour | Standard Deviation 625.5532 |
| Placebo | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 28 | 631.5519 Liter/hour | Standard Deviation 900.3648 |
| SRT2104 0.25 g/Day | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 1 | 621.3930 Liter/hour | Standard Deviation 948.1533 |
| SRT2104 0.25 g/Day | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 28 | 956.6848 Liter/hour | Standard Deviation 2117.3623 |
| SRT2104 0.5 g/Day | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 28 | 1420.2734 Liter/hour | Standard Deviation 2128.7769 |
| SRT2104 0.5 g/Day | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 1 | 1582.0131 Liter/hour | Standard Deviation 2707.3466 |
| SRT2104 1.0 g/Day | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 28 | 1887.2455 Liter/hour | Standard Deviation 2883.308 |
| SRT2104 1.0 g/Day | Apparent Total Clearance of SRT2104 From Plasma After Oral Administration (CL/F) on Day 1 and Day 28 | Day 1 | 2181.8596 Liter/hour | Standard Deviation 2959.1044 |
Primary
Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28
Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight.
Time frame: Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 1 | 12921.7880 mL/kg | Standard Deviation 19802.8598 |
| Placebo | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 28 | 17509.8071 mL/kg | Standard Deviation 27627.2504 |
| SRT2104 0.25 g/Day | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 28 | 48475.7739 mL/kg | Standard Deviation 150725.49 |
| SRT2104 0.25 g/Day | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 1 | 15767.2219 mL/kg | Standard Deviation 29059.757 |
| SRT2104 0.5 g/Day | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 1 | 38320.97415 mL/kg | Standard Deviation 77339.06047 |
| SRT2104 0.5 g/Day | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 28 | 56531.7676 mL/kg | Standard Deviation 108327.3925 |
| SRT2104 1.0 g/Day | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 1 | 32262.5089 mL/kg | Standard Deviation 45180.0346 |
| SRT2104 1.0 g/Day | Apparent Volume of Distribution After Oral Administration (Vd/F) at Day 1 and Day 28 | Day 28 | 51594.5474 mL/kg | Standard Deviation 93165.071 |
Primary
Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28
The pre-dose blood samples were collected within one hour prior to study medication administration. The post-dose blood samples were collected within 2 minutes of the scheduled time. AUC values reported in the analysis of AUC 0-infinity of Day 28 versus Day 1 included AUC 0-infinity on Day 1 and AUC 0-τ on Day 28. Participants fasted for at least 10 hour overnight on Day 1, 2 and 29. The AUC 0-t was determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations. AUC0-infinity was estimated by linear trapezoidal rule and was sum of the AUC0-t and extrapolated to infinity by dividing the estimated last measurable plasma concentration by elimination rate constant lambda z. Where lambda z is the terminal phase rate constant estimated by linear regression analysis of the log10 transformed concentration-time data after each single dose. The AUC0-infinity was the sum of the estimated and extrapolated parts.
Time frame: Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28)
Population: Pharmacokinetic (PK) Population defined as all participants who received SRT2104, had sufficient blood samples taken to obtain a plasma concentration time profile and who did not violate the protocol in such a way that it could influence the statistical analysis. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-t | 1549.6139 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 1450.1354 |
| Placebo | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-infinity | 2289.6858 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 1876.6537 |
| Placebo | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-infinity | 1564.4905 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 1119.348 |
| Placebo | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-τ | 1620.5989 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 1431.415 |
| Placebo | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-t | 1045.8420 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 978.3355 |
| SRT2104 0.25 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-t | 2731.6308 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2337.0839 |
| SRT2104 0.25 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-τ | 2731.6231 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2337.0919 |
| SRT2104 0.25 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-infinity | 4634.3397 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 5387.2429 |
| SRT2104 0.25 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-t | 2153.0075 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 1835.6039 |
| SRT2104 0.25 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-infinity | 2797.6930 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2287.3141 |
| SRT2104 0.5 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-t | 3109.8747 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2948.278 |
| SRT2104 0.5 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-t | 2375.3150 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2285.7123 |
| SRT2104 0.5 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-infinity | 3080.6902 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2532.8224 |
| SRT2104 0.5 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-infinity | 4960.3422 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 3914.026 |
| SRT2104 0.5 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-τ | 3212.6640 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2924.186 |
| SRT2104 1.0 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-τ | 4584.5679 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 4502.8752 |
| SRT2104 1.0 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-infinity | 8159.4534 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 7592.276 |
| SRT2104 1.0 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 28, AUC 0-t | 4380.2204 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 4476.9484 |
| SRT2104 1.0 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-infinity | 3837.1384 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 4078.697 |
| SRT2104 1.0 g/Day | Area Under Plasma Concentration Curve From Time 0 to Last Measurable Time Point (AUC 0-t), From Time 0 to Infinity (AUC 0-infinity) and From Time 0 to Trough Concentration (AUC 0-τ) of SRT2104 on Day 1 and Day 28 | Day 1, AUC 0-t | 2859.5465 Nanogram (ng)*hour/milliliter (mL) | Standard Deviation 2916.4783 |
Comparison: Day 28 versus Day 1 for AUC 0-t of SRT2104 0.25 g/day.90% CI: [123.87, 228.94]ANOVA
Comparison: Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.25 g/day.90% CI: [88.18, 139.43]ANOVA
Comparison: Day 28 versus Day 1 for AUC 0-t of SRT2104 0.5 g/day.90% CI: [100.55, 176.21]ANOVA
Comparison: Day 28 versus Day 1 for AUC 0-infinity of SRT2104 0.5 g/day.90% CI: [70.31, 126.48]ANOVA
Comparison: Day 28 versus Day 1 for AUC 0-t of SRT2104 1.0 g/day.90% CI: [111.2, 180.39]ANOVA
Comparison: Day 28 versus Day 1for AUC 0-infinity of SRT2104 1.0 g/day.90% CI: [85.56, 153.11]ANOVA
Comparison: Day 28 versus Day 1 for AUC 0-t of SRT2104 2.0 g/day.90% CI: [120.73, 231.25]ANOVA
Comparison: Day 28 versus Day 1 for AUC 0-infinity of SRT2104 2.0 g/day.90% CI: [85.14, 162.79]ANOVA
Primary
Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time
Assessment for albumin and total protein were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 28 | 0.45 Gram per liter | Standard Deviation 2.15 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 8 | -0.24 Gram per liter | Standard Deviation 3.33 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 35 | -0.02 Gram per liter | Standard Deviation 2.59 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 15 | 0.80 Gram per liter | Standard Deviation 2.44 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 35 | -0.05 Gram per liter | Standard Deviation 4.03 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 22 | 0.67 Gram per liter | Standard Deviation 1.91 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 8 | 0.29 Gram per liter | Standard Deviation 2.03 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 28 | 0.21 Gram per liter | Standard Deviation 3.76 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 22 | 0.48 Gram per liter | Standard Deviation 3.21 |
| Placebo | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 15 | 0.44 Gram per liter | Standard Deviation 4.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 22 | 0.82 Gram per liter | Standard Deviation 2.46 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 15 | 1.05 Gram per liter | Standard Deviation 2.39 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 28 | 0.00 Gram per liter | Standard Deviation 2.45 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 35 | -0.07 Gram per liter | Standard Deviation 2.08 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 15 | 0.67 Gram per liter | Standard Deviation 4.68 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 22 | 1.29 Gram per liter | Standard Deviation 5.54 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 28 | 0.06 Gram per liter | Standard Deviation 5.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 35 | -0.61 Gram per liter | Standard Deviation 3.94 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 8 | 0.80 Gram per liter | Standard Deviation 2.4 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 8 | 1.24 Gram per liter | Standard Deviation 4.39 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 28 | -1.10 Gram per liter | Standard Deviation 5.45 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 35 | -0.17 Gram per liter | Standard Deviation 2.56 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 8 | 0.23 Gram per liter | Standard Deviation 4.29 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 35 | -0.07 Gram per liter | Standard Deviation 4.66 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 15 | 0.63 Gram per liter | Standard Deviation 4.92 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 28 | -0.63 Gram per liter | Standard Deviation 2.79 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 22 | 0.49 Gram per liter | Standard Deviation 4.9 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 8 | 0.78 Gram per liter | Standard Deviation 2.72 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 22 | 0.10 Gram per liter | Standard Deviation 2.34 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 15 | 0.29 Gram per liter | Standard Deviation 2.39 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 28 | -0.32 Gram per liter | Standard Deviation 2.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 15 | -1.24 Gram per liter | Standard Deviation 4.28 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 22 | 0.55 Gram per liter | Standard Deviation 2.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 28 | -0.63 Gram per liter | Standard Deviation 3.76 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 22 | 0.18 Gram per liter | Standard Deviation 3.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 35 | -0.95 Gram per liter | Standard Deviation 4.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 8 | 0.64 Gram per liter | Standard Deviation 2.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 15 | 0.13 Gram per liter | Standard Deviation 2.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 35 | -0.16 Gram per liter | Standard Deviation 2.48 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 8 | 0.21 Gram per liter | Standard Deviation 3.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 8 | 1.24 Gram per liter | Standard Deviation 4.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 8 | 1.02 Gram per liter | Standard Deviation 1.93 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 22 | 0.40 Gram per liter | Standard Deviation 2.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 28 | -0.53 Gram per liter | Standard Deviation 2.4 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 35 | -0.21 Gram per liter | Standard Deviation 2.31 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Albumin, Day 15 | 0.53 Gram per liter | Standard Deviation 2.06 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 15 | -0.03 Gram per liter | Standard Deviation 4.38 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 35 | -1.57 Gram per liter | Standard Deviation 4.8 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 28 | -1.49 Gram per liter | Standard Deviation 4.48 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Albumin and Total Protein Over Time | Total protein, Day 22 | -0.03 Gram per liter | Standard Deviation 3.88 |
Primary
Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time
Assessment for bicarbonate, BUN, calcium, chloride, magnesium, phosphate, potassium and sodium were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 22 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 28 | 0.25 Micromole (mmol) per liter | Standard Deviation 1.39 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 28 | -0.17 Micromole (mmol) per liter | Standard Deviation 2.78 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 35 | -0.07 Micromole (mmol) per liter | Standard Deviation 1.51 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 22 | 0.57 Micromole (mmol) per liter | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 8 | 0.03 Micromole (mmol) per liter | Standard Deviation 0.09 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 15 | 0.85 Micromole (mmol) per liter | Standard Deviation 2.36 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 15 | 0.24 Micromole (mmol) per liter | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 8 | 0.45 Micromole (mmol) per liter | Standard Deviation 2.44 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 15 | 0.04 Micromole (mmol) per liter | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 35 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 22 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.08 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 15 | 0.10 Micromole (mmol) per liter | Standard Deviation 3.08 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 8 | 0.05 Micromole (mmol) per liter | Standard Deviation 2.48 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 22 | 0.65 Micromole (mmol) per liter | Standard Deviation 2.71 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 28 | -0.09 Micromole (mmol) per liter | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 35 | 0.25 Micromole (mmol) per liter | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 15 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 28 | 0.07 Micromole (mmol) per liter | Standard Deviation 2.87 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 28 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.43 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 8 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 15 | 0.04 Micromole (mmol) per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 22 | 0.19 Micromole (mmol) per liter | Standard Deviation 0.53 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 35 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 8 | 0.29 Micromole (mmol) per liter | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 15 | 0.23 Micromole (mmol) per liter | Standard Deviation 0.46 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 28 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 22 | 0.31 Micromole (mmol) per liter | Standard Deviation 2.42 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 28 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 35 | 0.68 Micromole (mmol) per liter | Standard Deviation 2.96 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 35 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 28 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.06 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 8 | -0.09 Micromole (mmol) per liter | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 35 | 0.71 Micromole (mmol) per liter | Standard Deviation 2.94 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 22 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.08 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 15 | -0.06 Micromole (mmol) per liter | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 8 | 0.74 Micromole (mmol) per liter | Standard Deviation 2.69 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 8 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.07 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 35 | 0.49 Micromole (mmol) per liter | Standard Deviation 3 |
| Placebo | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 22 | -0.03 Micromole (mmol) per liter | Standard Deviation 1.21 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 8 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 28 | 0.91 Micromole (mmol) per liter | Standard Deviation 2.11 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 8 | -0.14 Micromole (mmol) per liter | Standard Deviation 3.07 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 22 | 0.13 Micromole (mmol) per liter | Standard Deviation 0.4 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 22 | -0.26 Micromole (mmol) per liter | Standard Deviation 3.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 28 | 0.40 Micromole (mmol) per liter | Standard Deviation 2.66 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 35 | 0.35 Micromole (mmol) per liter | Standard Deviation 1.78 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 22 | 0.04 Micromole (mmol) per liter | Standard Deviation 0.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 8 | 0.78 Micromole (mmol) per liter | Standard Deviation 3.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 8 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 22 | 0.36 Micromole (mmol) per liter | Standard Deviation 2.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 15 | 0.16 Micromole (mmol) per liter | Standard Deviation 0.35 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 35 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.08 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 35 | -0.04 Micromole (mmol) per liter | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 15 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 15 | -0.53 Micromole (mmol) per liter | Standard Deviation 2.69 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 35 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.11 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 15 | 0.16 Micromole (mmol) per liter | Standard Deviation 2.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 8 | 0.11 Micromole (mmol) per liter | Standard Deviation 0.38 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 22 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 15 | 0.00 Micromole (mmol) per liter | Standard Deviation 3.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 22 | -0.46 Micromole (mmol) per liter | Standard Deviation 2.34 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 15 | 1.47 Micromole (mmol) per liter | Standard Deviation 2.68 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 8 | -0.33 Micromole (mmol) per liter | Standard Deviation 2.72 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 35 | 0.51 Micromole (mmol) per liter | Standard Deviation 2.61 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 35 | 0.98 Micromole (mmol) per liter | Standard Deviation 2.88 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 35 | 0.07 Micromole (mmol) per liter | Standard Deviation 2.78 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 8 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 28 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 35 | 0.07 Micromole (mmol) per liter | Standard Deviation 0.45 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 28 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 22 | 1.45 Micromole (mmol) per liter | Standard Deviation 2.69 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.07 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 22 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.07 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 28 | -0.11 Micromole (mmol) per liter | Standard Deviation 3.35 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 28 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 8 | 0.30 Micromole (mmol) per liter | Standard Deviation 2.05 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 28 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.52 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 28 | 0.17 Micromole (mmol) per liter | Standard Deviation 3.3 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 15 | 0.15 Micromole (mmol) per liter | Standard Deviation 1 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 8 | 0.62 Micromole (mmol) per liter | Standard Deviation 2.4 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 22 | 0.27 Micromole (mmol) per liter | Standard Deviation 1.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 35 | 0.22 Micromole (mmol) per liter | Standard Deviation 1.4 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 28 | -0.03 Micromole (mmol) per liter | Standard Deviation 0.12 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 8 | 0.46 Micromole (mmol) per liter | Standard Deviation 2.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 28 | 0.54 Micromole (mmol) per liter | Standard Deviation 3.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 35 | 1.40 Micromole (mmol) per liter | Standard Deviation 3 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 8 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 22 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 28 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 28 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 8 | 0.27 Micromole (mmol) per liter | Standard Deviation 0.45 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 15 | 0.41 Micromole (mmol) per liter | Standard Deviation 2.45 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 22 | 0.90 Micromole (mmol) per liter | Standard Deviation 2.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 28 | -0.37 Micromole (mmol) per liter | Standard Deviation 2.67 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 35 | 0.60 Micromole (mmol) per liter | Standard Deviation 2.65 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 8 | 0.29 Micromole (mmol) per liter | Standard Deviation 1.39 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 28 | 0.24 Micromole (mmol) per liter | Standard Deviation 1.29 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 8 | 0.03 Micromole (mmol) per liter | Standard Deviation 0.11 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 15 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 22 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 35 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.09 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 15 | 0.29 Micromole (mmol) per liter | Standard Deviation 2.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 22 | 0.45 Micromole (mmol) per liter | Standard Deviation 2.98 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 35 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 8 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 22 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 35 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 15 | 0.25 Micromole (mmol) per liter | Standard Deviation 0.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 22 | 0.28 Micromole (mmol) per liter | Standard Deviation 0.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 28 | 0.07 Micromole (mmol) per liter | Standard Deviation 0.37 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 35 | 0.23 Micromole (mmol) per liter | Standard Deviation 0.35 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 8 | 0.29 Micromole (mmol) per liter | Standard Deviation 2.62 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 15 | -0.31 Micromole (mmol) per liter | Standard Deviation 2.57 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 22 | 0.29 Micromole (mmol) per liter | Standard Deviation 2.8 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 28 | -0.15 Micromole (mmol) per liter | Standard Deviation 2.82 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 35 | 0.57 Micromole (mmol) per liter | Standard Deviation 3.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 22 | 1.10 Micromole (mmol) per liter | Standard Deviation 3.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 28 | -0.15 Micromole (mmol) per liter | Standard Deviation 1.49 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 35 | 1.38 Micromole (mmol) per liter | Standard Deviation 3.13 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 15 | 0.42 Micromole (mmol) per liter | Standard Deviation 1.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 22 | 0.00 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 35 | -0.14 Micromole (mmol) per liter | Standard Deviation 2.31 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 28 | -0.13 Micromole (mmol) per liter | Standard Deviation 2.42 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 35 | -0.57 Micromole (mmol) per liter | Standard Deviation 1.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 35 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.08 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 22 | 0.01 Micromole (mmol) per liter | Standard Deviation 1.46 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 8 | -0.03 Micromole (mmol) per liter | Standard Deviation 0.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 15 | -0.04 Micromole (mmol) per liter | Standard Deviation 0.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 22 | 0.03 Micromole (mmol) per liter | Standard Deviation 2.49 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 22 | 1.03 Micromole (mmol) per liter | Standard Deviation 3.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 22 | -0.03 Micromole (mmol) per liter | Standard Deviation 0.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 15 | 0.42 Micromole (mmol) per liter | Standard Deviation 2.52 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 8 | 0.15 Micromole (mmol) per liter | Standard Deviation 1.4 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 35 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 8 | 0.24 Micromole (mmol) per liter | Standard Deviation 0.47 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 15 | 0.34 Micromole (mmol) per liter | Standard Deviation 0.47 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 28 | -0.03 Micromole (mmol) per liter | Standard Deviation 0.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 35 | 1.10 Micromole (mmol) per liter | Standard Deviation 2.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 22 | 0.31 Micromole (mmol) per liter | Standard Deviation 0.51 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 28 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 28 | 0.73 Micromole (mmol) per liter | Standard Deviation 2.67 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 28 | 0.03 Micromole (mmol) per liter | Standard Deviation 0.48 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 8 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 35 | 0.20 Micromole (mmol) per liter | Standard Deviation 0.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 28 | 0.43 Micromole (mmol) per liter | Standard Deviation 3.27 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 8 | 0.05 Micromole (mmol) per liter | Standard Deviation 2.93 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 22 | 0.05 Micromole (mmol) per liter | Standard Deviation 0.08 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 28 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 15 | 0.05 Micromole (mmol) per liter | Standard Deviation 0.12 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 8 | 0.12 Micromole (mmol) per liter | Standard Deviation 2.82 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 35 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.08 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 8 | 0.05 Micromole (mmol) per liter | Standard Deviation 0.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 8 | 0.13 Micromole (mmol) per liter | Standard Deviation 2.48 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 15 | 0.90 Micromole (mmol) per liter | Standard Deviation 2.5 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 15 | 0.80 Micromole (mmol) per liter | Standard Deviation 2.9 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 15 | 0.13 Micromole (mmol) per liter | Standard Deviation 0.35 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 22 | -0.65 Micromole (mmol) per liter | Standard Deviation 3 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 22 | 0.16 Micromole (mmol) per liter | Standard Deviation 1.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 15 | 0.36 Micromole (mmol) per liter | Standard Deviation 1.46 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 8 | 0.03 Micromole (mmol) per liter | Standard Deviation 0.13 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 35 | 0.95 Micromole (mmol) per liter | Standard Deviation 3.09 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 8 | 0.02 Micromole (mmol) per liter | Standard Deviation 0.09 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 15 | -0.59 Micromole (mmol) per liter | Standard Deviation 3.19 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 22 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.09 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 15 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.04 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 8 | 0.03 Micromole (mmol) per liter | Standard Deviation 1.19 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 22 | 0.14 Micromole (mmol) per liter | Standard Deviation 0.4 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 22 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.08 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 35 | -0.48 Micromole (mmol) per liter | Standard Deviation 2.75 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 28 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.05 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 35 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 8 | -0.80 Micromole (mmol) per liter | Standard Deviation 2.72 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 28 | -0.04 Micromole (mmol) per liter | Standard Deviation 0.1 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.1 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 28 | -0.20 Micromole (mmol) per liter | Standard Deviation 0.31 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Magnesium, Day 8 | 0.01 Micromole (mmol) per liter | Standard Deviation 0.06 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 22 | 0.00 Micromole (mmol) per liter | Standard Deviation 2.6 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 35 | 0.24 Micromole (mmol) per liter | Standard Deviation 2.41 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 15 | -0.71 Micromole (mmol) per liter | Standard Deviation 3.39 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 15 | -0.01 Micromole (mmol) per liter | Standard Deviation 0.17 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 28 | -0.40 Micromole (mmol) per liter | Standard Deviation 3.09 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 35 | -0.11 Micromole (mmol) per liter | Standard Deviation 1.4 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 35 | 0.10 Micromole (mmol) per liter | Standard Deviation 0.42 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 22 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 15 | 0.03 Micromole (mmol) per liter | Standard Deviation 2.86 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Chloride, Day 28 | 0.00 Micromole (mmol) per liter | Standard Deviation 3.45 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | BUN, Day 28 | 0.09 Micromole (mmol) per liter | Standard Deviation 1.25 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 8 | -0.17 Micromole (mmol) per liter | Standard Deviation 2.64 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 35 | 0.04 Micromole (mmol) per liter | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Calcium, Day 35 | -0.02 Micromole (mmol) per liter | Standard Deviation 0.11 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Potassium, Day 8 | 0.19 Micromole (mmol) per liter | Standard Deviation 0.42 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 22 | -0.63 Micromole (mmol) per liter | Standard Deviation 2.83 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Phosphate, Day 28 | -0.00 Micromole (mmol) per liter | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Bicarbonate, Day 28 | -0.68 Micromole (mmol) per liter | Standard Deviation 1.97 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Bicarbonate, Blood Urea Nitrogen (BUN), Calcium, Chloride, Magnesium, Phosphate, Potassium and Sodium Over Time | Sodium, Day 8 | -0.41 Micromole (mmol) per liter | Standard Deviation 2.74 |
Primary
Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time
Assessment for direct bilirubin, indirect bilirubin, serum creatinine, total bilirubin and uric acid were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 22 | 0.98 Micromole per liter | Standard Deviation 3.75 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 8 | 1.38 Micromole per liter | Standard Deviation 38.94 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 35 | -0.38 Micromole per liter | Standard Deviation 3.37 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 8 | -0.49 Micromole per liter | Standard Deviation 3.72 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 22 | 0.19 Micromole per liter | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 8 | 0.31 Micromole per liter | Standard Deviation 6.78 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 35 | -0.62 Micromole per liter | Standard Deviation 4.24 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 15 | -1.05 Micromole per liter | Standard Deviation 6.8 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 35 | 2.30 Micromole per liter | Standard Deviation 55.55 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 28 | -0.08 Micromole per liter | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 22 | -0.74 Micromole per liter | Standard Deviation 6.97 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 15 | 0.11 Micromole per liter | Standard Deviation 0.68 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 28 | -1.12 Micromole per liter | Standard Deviation 7.38 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 15 | -5.95 Micromole per liter | Standard Deviation 59.07 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 28 | 5.69 Micromole per liter | Standard Deviation 50.16 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 35 | -0.06 Micromole per liter | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 35 | -0.75 Micromole per liter | Standard Deviation 7.5 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 22 | -1.40 Micromole per liter | Standard Deviation 46.23 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 8 | -0.30 Micromole per liter | Standard Deviation 3.02 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 15 | 0.44 Micromole per liter | Standard Deviation 3.16 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 15 | 0.31 Micromole per liter | Standard Deviation 2.47 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 28 | -0.64 Micromole per liter | Standard Deviation 4.17 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 22 | 0.70 Micromole per liter | Standard Deviation 3.44 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 8 | -0.05 Micromole per liter | Standard Deviation 0.88 |
| Placebo | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 28 | -0.58 Micromole per liter | Standard Deviation 3.59 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 35 | 0.07 Micromole per liter | Standard Deviation 9.91 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 8 | 0.26 Micromole per liter | Standard Deviation 0.78 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 22 | 1.05 Micromole per liter | Standard Deviation 3.38 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 15 | 0.71 Micromole per liter | Standard Deviation 4.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 35 | -0.38 Micromole per liter | Standard Deviation 3.56 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 15 | 1.25 Micromole per liter | Standard Deviation 4.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 35 | -0.06 Micromole per liter | Standard Deviation 0.6 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 22 | 0.10 Micromole per liter | Standard Deviation 0.7 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 28 | 0.04 Micromole per liter | Standard Deviation 3.21 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 8 | 1.68 Micromole per liter | Standard Deviation 8.98 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 8 | 1.24 Micromole per liter | Standard Deviation 3.73 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 15 | -13.19 Micromole per liter | Standard Deviation 54.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 35 | -0.33 Micromole per liter | Standard Deviation 3.72 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 35 | -8.63 Micromole per liter | Standard Deviation 57.75 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 15 | 1.00 Micromole per liter | Standard Deviation 8.91 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 28 | 6.20 Micromole per liter | Standard Deviation 74.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 8 | -8.66 Micromole per liter | Standard Deviation 55.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 8 | 1.06 Micromole per liter | Standard Deviation 3.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 15 | 0.19 Micromole per liter | Standard Deviation 0.6 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 22 | 1.13 Micromole per liter | Standard Deviation 10.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 28 | 0.07 Micromole per liter | Standard Deviation 0.38 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 22 | -3.55 Micromole per liter | Standard Deviation 53.46 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 28 | 0.17 Micromole per liter | Standard Deviation 3.46 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 22 | 0.61 Micromole per liter | Standard Deviation 3.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 28 | 1.09 Micromole per liter | Standard Deviation 9.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 15 | 2.21 Micromole per liter | Standard Deviation 6.97 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 35 | 0.93 Micromole per liter | Standard Deviation 6.87 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 8 | 1.77 Micromole per liter | Standard Deviation 4.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 15 | 0.13 Micromole per liter | Standard Deviation 0.52 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 22 | 0.83 Micromole per liter | Standard Deviation 3.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 15 | 0.73 Micromole per liter | Standard Deviation 2.95 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 28 | -10.73 Micromole per liter | Standard Deviation 41.62 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 22 | 0.08 Micromole per liter | Standard Deviation 0.35 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 28 | 0.19 Micromole per liter | Standard Deviation 0.74 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 35 | -0.05 Micromole per liter | Standard Deviation 0.32 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 8 | 1.49 Micromole per liter | Standard Deviation 3.52 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 15 | -20.29 Micromole per liter | Standard Deviation 39.59 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 15 | 0.56 Micromole per liter | Standard Deviation 2.55 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 22 | -21.63 Micromole per liter | Standard Deviation 52.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 8 | -22.90 Micromole per liter | Standard Deviation 48.36 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 22 | 0.62 Micromole per liter | Standard Deviation 3.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 28 | 0.38 Micromole per liter | Standard Deviation 2.69 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 35 | -0.08 Micromole per liter | Standard Deviation 2.95 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 8 | 0.27 Micromole per liter | Standard Deviation 0.65 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 35 | -0.32 Micromole per liter | Standard Deviation 3.39 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 8 | 4.27 Micromole per liter | Standard Deviation 8.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 35 | -4.51 Micromole per liter | Standard Deviation 56.6 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 28 | 1.85 Micromole per liter | Standard Deviation 9.47 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 28 | 0.90 Micromole per liter | Standard Deviation 3.39 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 22 | 2.57 Micromole per liter | Standard Deviation 7.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 22 | 1.76 Micromole per liter | Standard Deviation 3.97 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 8 | 0.13 Micromole per liter | Standard Deviation 0.55 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 15 | -0.06 Micromole per liter | Standard Deviation 0.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 22 | 0.03 Micromole per liter | Standard Deviation 0.74 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 28 | -0.11 Micromole per liter | Standard Deviation 0.5 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 35 | -0.25 Micromole per liter | Standard Deviation 0.67 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 8 | 0.91 Micromole per liter | Standard Deviation 3.32 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 15 | 0.52 Micromole per liter | Standard Deviation 3.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 22 | 1.09 Micromole per liter | Standard Deviation 3.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 28 | -0.36 Micromole per liter | Standard Deviation 2.68 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 35 | -1.63 Micromole per liter | Standard Deviation 3.9 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 8 | 5.26 Micromole per liter | Standard Deviation 9.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 15 | 2.45 Micromole per liter | Standard Deviation 8.3 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 22 | 2.61 Micromole per liter | Standard Deviation 9.49 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 35 | -1.46 Micromole per liter | Standard Deviation 6.89 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 8 | 1.39 Micromole per liter | Standard Deviation 3.78 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 15 | 1.68 Micromole per liter | Standard Deviation 4.87 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 28 | 1.03 Micromole per liter | Standard Deviation 6.89 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 28 | 0.30 Micromole per liter | Standard Deviation 4.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 35 | -1.81 Micromole per liter | Standard Deviation 5.34 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 8 | -20.95 Micromole per liter | Standard Deviation 61.72 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 15 | -11.13 Micromole per liter | Standard Deviation 74.79 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 22 | -13.61 Micromole per liter | Standard Deviation 57.87 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 28 | -6.00 Micromole per liter | Standard Deviation 61.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 35 | 12.03 Micromole per liter | Standard Deviation 59.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 8 | 7.15 Micromole per liter | Standard Deviation 10.89 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 35 | -1.24 Micromole per liter | Standard Deviation 2.78 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 28 | -18.05 Micromole per liter | Standard Deviation 82.41 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 35 | -1.39 Micromole per liter | Standard Deviation 3.28 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 28 | -0.37 Micromole per liter | Standard Deviation 3.53 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 22 | 0.39 Micromole per liter | Standard Deviation 2.69 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 15 | 1.22 Micromole per liter | Standard Deviation 2.9 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 8 | 0.30 Micromole per liter | Standard Deviation 0.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 8 | -26.20 Micromole per liter | Standard Deviation 66.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Indirect bilirubin, Day 8 | 1.22 Micromole per liter | Standard Deviation 4.36 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 28 | -0.03 Micromole per liter | Standard Deviation 5.22 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 15 | -7.70 Micromole per liter | Standard Deviation 63.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 35 | 0.00 Micromole per liter | Standard Deviation 0.53 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 28 | 2.78 Micromole per liter | Standard Deviation 9.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 22 | -13.88 Micromole per liter | Standard Deviation 70.17 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 28 | 0.26 Micromole per liter | Standard Deviation 0.85 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 22 | 0.21 Micromole per liter | Standard Deviation 0.58 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 15 | 1.95 Micromole per liter | Standard Deviation 4.42 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 8 | 2.08 Micromole per liter | Standard Deviation 6.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Direct bilirubin, Day 15 | 0.43 Micromole per liter | Standard Deviation 0.9 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Total bilirubin, Day 22 | 1.21 Micromole per liter | Standard Deviation 4.57 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 35 | 0.40 Micromole per liter | Standard Deviation 8 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 22 | 5.50 Micromole per liter | Standard Deviation 8.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Serum creatinine, Day 15 | 5.83 Micromole per liter | Standard Deviation 10.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Direct Bilirubin, Indirect Bilirubin, Serum Creatinine, Total Bilirubin and Uric Acid Over Time | Uric acid, Day 35 | -2.45 Micromole per liter | Standard Deviation 57.67 |
Primary
Change From Baseline in Chemistry Parameter of Lipid Profile Over Time
Assessment for lipid profile was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. The parameters included high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol and triglycerides. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 15 | -0.07 mmol per liter | Standard Deviation 0.53 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 15 | -0.02 mmol per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 8 | -0.10 mmol per liter | Standard Deviation 0.57 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 35 | -0.03 mmol per liter | Standard Deviation 0.22 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 28 | -0.04 mmol per liter | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 22 | -0.03 mmol per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 22 | -0.08 mmol per liter | Standard Deviation 1.03 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 28 | -0.07 mmol per liter | Standard Deviation 0.69 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 22 | -0.09 mmol per liter | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 28 | -0.08 mmol per liter | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 28 | -0.15 mmol per liter | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 15 | 0.04 mmol per liter | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 8 | -0.15 mmol per liter | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 35 | -0.11 mmol per liter | Standard Deviation 0.98 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 15 | -0.09 mmol per liter | Standard Deviation 0.71 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 22 | -0.02 mmol per liter | Standard Deviation 0.68 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 8 | -0.02 mmol per liter | Standard Deviation 0.14 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 35 | -0.02 mmol per liter | Standard Deviation 0.83 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 8 | -0.16 mmol per liter | Standard Deviation 0.62 |
| Placebo | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 35 | -0.08 mmol per liter | Standard Deviation 0.71 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 35 | -0.47 mmol per liter | Standard Deviation 0.88 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 8 | -0.27 mmol per liter | Standard Deviation 0.76 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 22 | -0.34 mmol per liter | Standard Deviation 0.67 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 22 | -0.46 mmol per liter | Standard Deviation 0.81 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 15 | 0.01 mmol per liter | Standard Deviation 0.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 8 | 0.01 mmol per liter | Standard Deviation 0.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 22 | 0.02 mmol per liter | Standard Deviation 0.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 28 | -0.02 mmol per liter | Standard Deviation 0.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 15 | -0.26 mmol per liter | Standard Deviation 0.83 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 28 | -0.17 mmol per liter | Standard Deviation 0.77 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 35 | -0.30 mmol per liter | Standard Deviation 0.83 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 8 | -0.33 mmol per liter | Standard Deviation 0.89 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 15 | -0.38 mmol per liter | Standard Deviation 0.97 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 28 | -0.23 mmol per liter | Standard Deviation 0.93 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 35 | 0.00 mmol per liter | Standard Deviation 0.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 8 | -0.14 mmol per liter | Standard Deviation 1.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 15 | -0.34 mmol per liter | Standard Deviation 1.36 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 22 | -0.36 mmol per liter | Standard Deviation 1.3 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 28 | -0.09 mmol per liter | Standard Deviation 1.6 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 35 | -0.30 mmol per liter | Standard Deviation 0.81 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 22 | -0.14 mmol per liter | Standard Deviation 0.88 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 35 | -0.22 mmol per liter | Standard Deviation 1.07 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 28 | 0.22 mmol per liter | Standard Deviation 0.95 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 8 | -0.16 mmol per liter | Standard Deviation 0.57 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 15 | -0.27 mmol per liter | Standard Deviation 0.98 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 22 | -0.02 mmol per liter | Standard Deviation 0.97 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 28 | -0.25 mmol per liter | Standard Deviation 0.89 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 22 | -0.16 mmol per liter | Standard Deviation 1.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 28 | -0.29 mmol per liter | Standard Deviation 0.75 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 35 | -0.32 mmol per liter | Standard Deviation 3.03 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 15 | -0.23 mmol per liter | Standard Deviation 0.76 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 22 | 0.02 mmol per liter | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 15 | -0.01 mmol per liter | Standard Deviation 0.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 28 | -0.04 mmol per liter | Standard Deviation 0.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 35 | -0.14 mmol per liter | Standard Deviation 0.77 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 35 | -0.01 mmol per liter | Standard Deviation 0.22 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 15 | 0.02 mmol per liter | Standard Deviation 1.23 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 8 | 0.02 mmol per liter | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 8 | -0.22 mmol per liter | Standard Deviation 0.76 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 8 | -0.27 mmol per liter | Standard Deviation 0.72 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 8 | -0.19 mmol per liter | Standard Deviation 0.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 15 | -0.22 mmol per liter | Standard Deviation 0.61 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 22 | -0.23 mmol per liter | Standard Deviation 0.52 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 28 | -0.28 mmol per liter | Standard Deviation 0.59 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 8 | 0.05 mmol per liter | Standard Deviation 0.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 22 | -0.83 mmol per liter | Standard Deviation 1.89 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 35 | -0.15 mmol per liter | Standard Deviation 0.5 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 8 | -0.38 mmol per liter | Standard Deviation 0.5 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 15 | -0.35 mmol per liter | Standard Deviation 0.82 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 22 | -0.49 mmol per liter | Standard Deviation 0.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 28 | -0.55 mmol per liter | Standard Deviation 0.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 35 | -0.90 mmol per liter | Standard Deviation 2.29 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 35 | -0.41 mmol per liter | Standard Deviation 0.93 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 8 | -0.66 mmol per liter | Standard Deviation 1.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 28 | -0.75 mmol per liter | Standard Deviation 1.91 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 15 | -0.50 mmol per liter | Standard Deviation 0.97 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 22 | 0.05 mmol per liter | Standard Deviation 0.14 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 28 | 0.01 mmol per liter | Standard Deviation 0.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 15 | 0.08 mmol per liter | Standard Deviation 0.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 35 | 0.05 mmol per liter | Standard Deviation 0.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 28 | -0.05 mmol per liter | Standard Deviation 0.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 8 | -0.13 mmol per liter | Standard Deviation 0.63 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 22 | 0.08 mmol per liter | Standard Deviation 1.32 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 28 | 0.03 mmol per liter | Standard Deviation 1.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 35 | -0.07 mmol per liter | Standard Deviation 0.86 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 8 | -0.03 mmol per liter | Standard Deviation 0.17 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 15 | 0.07 mmol per liter | Standard Deviation 1.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 28 | -0.22 mmol per liter | Standard Deviation 0.86 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 8 | -0.20 mmol per liter | Standard Deviation 0.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 22 | -0.04 mmol per liter | Standard Deviation 0.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 22 | -0.20 mmol per liter | Standard Deviation 0.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 15 | -0.27 mmol per liter | Standard Deviation 0.72 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 15 | -0.03 mmol per liter | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 28 | -0.23 mmol per liter | Standard Deviation 0.92 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 22 | -0.17 mmol per liter | Standard Deviation 0.74 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Triglycerides, Day 35 | -0.19 mmol per liter | Standard Deviation 0.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 8 | -0.27 mmol per liter | Standard Deviation 0.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | LDL, Day 15 | -0.26 mmol per liter | Standard Deviation 0.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | Total cholesterol, Day 35 | -0.11 mmol per liter | Standard Deviation 1.04 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameter of Lipid Profile Over Time | HDL, Day 35 | -0.01 mmol per liter | Standard Deviation 0.18 |
Primary
Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time
Assessment for ALT, AST, ALP, creatinine phosphokinase and LDH were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 35 | -7.47 International units per liter | Standard Deviation 60.72 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 15 | -9.03 International units per liter | Standard Deviation 39.62 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 8 | -3.22 International units per liter | Standard Deviation 7.6 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 28 | -3.74 International units per liter | Standard Deviation 51.3 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 35 | -4.65 International units per liter | Standard Deviation 23.19 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 35 | -2.14 International units per liter | Standard Deviation 11.95 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 28 | -2.28 International units per liter | Standard Deviation 11.28 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 8 | 0.90 International units per liter | Standard Deviation 8.33 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 22 | 0.28 International units per liter | Standard Deviation 33.55 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 28 | -11.27 International units per liter | Standard Deviation 56.13 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 8 | -9.27 International units per liter | Standard Deviation 55.02 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 22 | -1.36 International units per liter | Standard Deviation 11.82 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 15 | 1.03 International units per liter | Standard Deviation 15.17 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 28 | -4.73 International units per liter | Standard Deviation 12.2 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 8 | -4.05 International units per liter | Standard Deviation 30.14 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 15 | -3.31 International units per liter | Standard Deviation 52.15 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 15 | -0.97 International units per liter | Standard Deviation 13.71 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 22 | 0.13 International units per liter | Standard Deviation 13.64 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 22 | -3.17 International units per liter | Standard Deviation 10.1 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 35 | -2.49 International units per liter | Standard Deviation 11.86 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 22 | -8.84 International units per liter | Standard Deviation 58.19 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 8 | -1.33 International units per liter | Standard Deviation 10.28 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 28 | -2.79 International units per liter | Standard Deviation 11.14 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 15 | -1.61 International units per liter | Standard Deviation 15.02 |
| Placebo | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 35 | -5.95 International units per liter | Standard Deviation 12.74 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 8 | 0.03 International units per liter | Standard Deviation 20.69 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 28 | -1.34 International units per liter | Standard Deviation 19.89 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 35 | -0.38 International units per liter | Standard Deviation 9.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 22 | -0.55 International units per liter | Standard Deviation 17.35 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 8 | -0.63 International units per liter | Standard Deviation 9.8 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 28 | 2.61 International units per liter | Standard Deviation 32.25 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 15 | -4.17 International units per liter | Standard Deviation 14.55 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 35 | 0.38 International units per liter | Standard Deviation 31.87 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 22 | 27.54 International units per liter | Standard Deviation 97.86 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 28 | -1.39 International units per liter | Standard Deviation 6.93 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 15 | 0.58 International units per liter | Standard Deviation 20.51 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 15 | 4.46 International units per liter | Standard Deviation 33.64 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 22 | -0.33 International units per liter | Standard Deviation 21.26 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 35 | -1.74 International units per liter | Standard Deviation 20.9 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 8 | 11.25 International units per liter | Standard Deviation 79.26 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 28 | -5.04 International units per liter | Standard Deviation 19.71 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 35 | -1.38 International units per liter | Standard Deviation 6.52 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 8 | -0.90 International units per liter | Standard Deviation 6.99 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 22 | 1.47 International units per liter | Standard Deviation 6.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 15 | -0.54 International units per liter | Standard Deviation 7.99 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 15 | -0.54 International units per liter | Standard Deviation 6.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 22 | 3.05 International units per liter | Standard Deviation 13.37 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 35 | -2.10 International units per liter | Standard Deviation 15.76 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 8 | -1.25 International units per liter | Standard Deviation 6.3 |
| SRT2104 0.25 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 28 | 0.56 International units per liter | Standard Deviation 13.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 22 | -19.40 International units per liter | Standard Deviation 74.31 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 28 | -0.69 International units per liter | Standard Deviation 9.92 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 8 | -10.95 International units per liter | Standard Deviation 84.04 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 28 | -15.03 International units per liter | Standard Deviation 84.44 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 8 | 1.51 International units per liter | Standard Deviation 20.44 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 22 | -2.34 International units per liter | Standard Deviation 22.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 35 | 2.19 International units per liter | Standard Deviation 25.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 8 | 1.18 International units per liter | Standard Deviation 10.46 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 15 | -0.21 International units per liter | Standard Deviation 10.54 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 22 | -0.41 International units per liter | Standard Deviation 10.98 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 28 | -0.47 International units per liter | Standard Deviation 13.17 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 35 | -0.97 International units per liter | Standard Deviation 10.85 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 8 | -1.60 International units per liter | Standard Deviation 8.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 15 | -2.05 International units per liter | Standard Deviation 12.83 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 22 | -0.22 International units per liter | Standard Deviation 13.95 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 35 | -2.71 International units per liter | Standard Deviation 13.71 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 8 | -0.63 International units per liter | Standard Deviation 6.92 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 15 | -0.38 International units per liter | Standard Deviation 9.6 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 22 | -0.95 International units per liter | Standard Deviation 11.51 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 35 | -0.82 International units per liter | Standard Deviation 10.05 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 15 | -10.23 International units per liter | Standard Deviation 77.79 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 28 | -3.33 International units per liter | Standard Deviation 14.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 35 | -12.58 International units per liter | Standard Deviation 82.07 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 15 | -2.45 International units per liter | Standard Deviation 23.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 28 | -7.44 International units per liter | Standard Deviation 18.31 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 28 | -2.27 International units per liter | Standard Deviation 9.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 8 | -5.23 International units per liter | Standard Deviation 18.38 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 35 | -6.34 International units per liter | Standard Deviation 16.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 22 | -0.21 International units per liter | Standard Deviation 9.78 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 8 | -1.18 International units per liter | Standard Deviation 10.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 15 | -2.69 International units per liter | Standard Deviation 6.69 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 15 | -2.85 International units per liter | Standard Deviation 11.39 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 8 | -1.53 International units per liter | Standard Deviation 6.48 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 15 | -6.09 International units per liter | Standard Deviation 29.6 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 22 | -0.97 International units per liter | Standard Deviation 12.87 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 28 | -2.23 International units per liter | Standard Deviation 11.76 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 35 | -1.65 International units per liter | Standard Deviation 23.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 35 | -1.88 International units per liter | Standard Deviation 12.15 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 8 | -3.11 International units per liter | Standard Deviation 30.12 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 22 | -3.61 International units per liter | Standard Deviation 22.03 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 28 | -4.61 International units per liter | Standard Deviation 18.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 15 | -7.06 International units per liter | Standard Deviation 43.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 28 | -6.70 International units per liter | Standard Deviation 16.99 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 22 | 6.47 International units per liter | Standard Deviation 33.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 28 | 12.65 International units per liter | Standard Deviation 40.68 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 35 | 8.30 International units per liter | Standard Deviation 33.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 15 | -5.67 International units per liter | Standard Deviation 18.08 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 8 | -3.24 International units per liter | Standard Deviation 9 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 22 | -2.08 International units per liter | Standard Deviation 19.56 |
| SRT2104 1.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 35 | -3.06 International units per liter | Standard Deviation 9.14 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 8 | 0.63 International units per liter | Standard Deviation 9.9 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 8 | -8.37 International units per liter | Standard Deviation 100 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 28 | -3.86 International units per liter | Standard Deviation 11.1 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 22 | -3.71 International units per liter | Standard Deviation 11.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 15 | -2.64 International units per liter | Standard Deviation 16.74 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 8 | -0.54 International units per liter | Standard Deviation 14.93 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 22 | -2.20 International units per liter | Standard Deviation 12.29 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 8 | 0.46 International units per liter | Standard Deviation 4.89 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 15 | -1.95 International units per liter | Standard Deviation 8.92 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 15 | -1.65 International units per liter | Standard Deviation 10.35 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 35 | -4.69 International units per liter | Standard Deviation 16.79 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 15 | -0.05 International units per liter | Standard Deviation 101.77 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 15 | 0.37 International units per liter | Standard Deviation 5.27 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 8 | -0.46 International units per liter | Standard Deviation 8.49 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 35 | -4.33 International units per liter | Standard Deviation 104.54 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 28 | -3.47 International units per liter | Standard Deviation 110.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALP, Day 28 | -4.05 International units per liter | Standard Deviation 15.79 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 22 | -1.50 International units per liter | Standard Deviation 6.33 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 35 | -3.68 International units per liter | Standard Deviation 16.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | ALT, Day 35 | -3.13 International units per liter | Standard Deviation 11.78 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 28 | -1.44 International units per liter | Standard Deviation 4.95 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | Creatinine phosphokinase, Day 22 | -9.18 International units per liter | Standard Deviation 100.75 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | AST, Day 35 | -1.88 International units per liter | Standard Deviation 5.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 28 | -1.48 International units per liter | Standard Deviation 16.83 |
| SRT2104 2.0 g/Day | Change From Baseline in Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotrasferase (AST), Alkaline Phosphatase (ALP), Creatinine Phosphokinase and Lactate Dehydrogenase (LDH) Over Time | LDH, Day 22 | -3.42 International units per liter | Standard Deviation 16.53 |
Primary
Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time
Assessment for international normalized ratio was performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.
Time frame: Baseline (Day 1), Day 28 and Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 28 | -0.02 Ratio | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 35 | -0.04 Ratio | Standard Deviation 0.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 35 | -0.03 Ratio | Standard Deviation 0.09 |
| SRT2104 0.25 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 28 | 0.02 Ratio | Standard Deviation 0.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 28 | 0.01 Ratio | Standard Deviation 0.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 35 | -0.02 Ratio | Standard Deviation 0.07 |
| SRT2104 1.0 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 28 | -0.01 Ratio | Standard Deviation 0.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 35 | -0.04 Ratio | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 35 | -0.04 Ratio | Standard Deviation 0.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Coagulation Parameter of International Normalized Ratio Over Time | Day 28 | -0.03 Ratio | Standard Deviation 0.16 |
Primary
Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time
Assessment for aPTT and PT were performed on Day 1, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.
Time frame: Baseline (Day 1), Day 28 and Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 28 | -0.28 Seconds | Standard Deviation 1.62 |
| Placebo | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 35 | -0.43 Seconds | Standard Deviation 6.99 |
| Placebo | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 35 | -0.49 Seconds | Standard Deviation 1.62 |
| Placebo | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 28 | 0.53 Seconds | Standard Deviation 6.78 |
| SRT2104 0.25 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 28 | 0.18 Seconds | Standard Deviation 2.68 |
| SRT2104 0.25 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 28 | 1.51 Seconds | Standard Deviation 9.88 |
| SRT2104 0.25 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 35 | -0.45 Seconds | Standard Deviation 1.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 35 | -1.73 Seconds | Standard Deviation 4.28 |
| SRT2104 0.5 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 28 | 0.20 Seconds | Standard Deviation 2.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 35 | -1.46 Seconds | Standard Deviation 4.31 |
| SRT2104 0.5 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 28 | -1.58 Seconds | Standard Deviation 6.98 |
| SRT2104 0.5 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 35 | -0.26 Seconds | Standard Deviation 0.83 |
| SRT2104 1.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 35 | -1.28 Seconds | Standard Deviation 4.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 28 | 1.41 Seconds | Standard Deviation 13.03 |
| SRT2104 1.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 28 | -0.18 Seconds | Standard Deviation 1.43 |
| SRT2104 1.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 35 | -0.47 Seconds | Standard Deviation 2.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 28 | 1.26 Seconds | Standard Deviation 10.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | aPTT, Day 35 | -0.84 Seconds | Standard Deviation 5.26 |
| SRT2104 2.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 35 | -0.44 Seconds | Standard Deviation 0.94 |
| SRT2104 2.0 g/Day | Change From Baseline in Coagulation Parameters of Activated Partial Thromplastin Time (aPTT) and Prothrombin Time (PT) Over Time | PT, Day 28 | -0.36 Seconds | Standard Deviation 1.99 |
Primary
Change From Baseline in Electrocardiogram (ECG) Values Over Time
12-lead ECG was obtained in the rested state. Participants lied in supine position with ECG leads on for at least 5 minutes prior to ECG recording. The ECG was performed at Day 1 (pre-dose and post-dose), Day 8, Day 15, Day 22, Day 28 (pre-dose and pre-dose) and Day 35, and included the assessment of PR interval, QRS interval, QT interval and QTc interval. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1 \[post-dose\], Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1, pre-dose) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 8 | -0.50 Millisecond | Standard Deviation 7.74 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 1, post-dose | -0.83 Millisecond | Standard Deviation 8.31 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 35 | -0.07 Millisecond | Standard Deviation 16.43 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, pre-dose | -0.55 Millisecond | Standard Deviation 14.81 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 22 | -2.38 Millisecond | Standard Deviation 16.84 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 8 | 5.02 Millisecond | Standard Deviation 21.98 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 1, post-dose | 0.12 Millisecond | Standard Deviation 9.92 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 1, post-dose | -2.52 Millisecond | Standard Deviation 16.05 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, pre-dose | 4.98 Millisecond | Standard Deviation 17.02 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 15 | -5.79 Millisecond | Standard Deviation 15.29 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 22 | 3.21 Millisecond | Standard Deviation 17.87 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, post-dose | -1.98 Millisecond | Standard Deviation 15.72 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 8 | -0.26 Millisecond | Standard Deviation 17.29 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 15 | -0.57 Millisecond | Standard Deviation 21.03 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 35 | 2.10 Millisecond | Standard Deviation 22.76 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, post-dose | 0.90 Millisecond | Standard Deviation 34.52 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, pre-dose | 9.17 Millisecond | Standard Deviation 25.76 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 35 | 2.38 Millisecond | Standard Deviation 19.88 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 22 | 1.38 Millisecond | Standard Deviation 20.93 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 15 | 0.93 Millisecond | Standard Deviation 23.43 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 22 | 0.14 Millisecond | Standard Deviation 5.88 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, post-dose | 2.05 Millisecond | Standard Deviation 21.32 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 8 | -1.17 Millisecond | Standard Deviation 18.65 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 1, post-dose | -0.29 Millisecond | Standard Deviation 14.09 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, post-dose | -0.14 Millisecond | Standard Deviation 11.71 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, pre-dose | -0.81 Millisecond | Standard Deviation 9.55 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 15 | -1.05 Millisecond | Standard Deviation 6.89 |
| Placebo | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 35 | -0.36 Millisecond | Standard Deviation 6.55 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 22 | 1.31 Millisecond | Standard Deviation 21.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 1, post-dose | 1.47 Millisecond | Standard Deviation 13.07 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 8 | -3.42 Millisecond | Standard Deviation 18.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 15 | -3.20 Millisecond | Standard Deviation 16.45 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, pre-dose | -3.46 Millisecond | Standard Deviation 18.59 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, post-dose | -1.22 Millisecond | Standard Deviation 17.4 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 8 | -17.49 Millisecond | Standard Deviation 107.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 22 | -19.31 Millisecond | Standard Deviation 112.93 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 22 | -0.31 Millisecond | Standard Deviation 18.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 35 | -1.22 Millisecond | Standard Deviation 25.54 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 1, post-dose | 1.07 Millisecond | Standard Deviation 9.67 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 15 | -16.15 Millisecond | Standard Deviation 110.73 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, pre-dose | -20.00 Millisecond | Standard Deviation 120.11 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, post-dose | -19.38 Millisecond | Standard Deviation 120.28 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 35 | -12.39 Millisecond | Standard Deviation 112.59 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 1, post-dose | -2.44 Millisecond | Standard Deviation 20.72 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 8 | -7.56 Millisecond | Standard Deviation 32.44 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 15 | 0.40 Millisecond | Standard Deviation 21.66 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, pre-dose | 1.62 Millisecond | Standard Deviation 19.05 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, post-dose | 4.27 Millisecond | Standard Deviation 18.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 35 | 4.56 Millisecond | Standard Deviation 22.44 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 1, post-dose | -1.60 Millisecond | Standard Deviation 16.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 8 | -3.40 Millisecond | Standard Deviation 27.38 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 15 | -3.05 Millisecond | Standard Deviation 26.25 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 22 | -4.21 Millisecond | Standard Deviation 17.59 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, pre-dose | 2.35 Millisecond | Standard Deviation 18.9 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, post-dose | 0.54 Millisecond | Standard Deviation 21.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 35 | -0.05 Millisecond | Standard Deviation 21.78 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 8 | 0.81 Millisecond | Standard Deviation 6.78 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 1, post-dose | 1.28 Millisecond | Standard Deviation 14.46 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 22 | -0.26 Millisecond | Standard Deviation 7.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, pre-dose | -2.39 Millisecond | Standard Deviation 14.43 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 35 | 0.36 Millisecond | Standard Deviation 20.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 8 | 0.45 Millisecond | Standard Deviation 14.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, post-dose | 2.39 Millisecond | Standard Deviation 23.09 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 35 | 0.48 Millisecond | Standard Deviation 19.88 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 15 | -0.17 Millisecond | Standard Deviation 6.26 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 22 | 1.36 Millisecond | Standard Deviation 22.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 1, post-dose | 0.58 Millisecond | Standard Deviation 12.43 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, pre-dose | 1.46 Millisecond | Standard Deviation 27.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 15 | -0.66 Millisecond | Standard Deviation 22.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 22 | -1.19 Millisecond | Standard Deviation 14.86 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 22 | 5.52 Millisecond | Standard Deviation 17.55 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, post-dose | 3.80 Millisecond | Standard Deviation 24.89 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 15 | 2.78 Millisecond | Standard Deviation 15.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, pre-dose | -0.54 Millisecond | Standard Deviation 6.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 1, post-dose | -0.16 Millisecond | Standard Deviation 3.31 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, post-dose | -1.59 Millisecond | Standard Deviation 16.55 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 8 | 3.64 Millisecond | Standard Deviation 20.77 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 8 | -2.74 Millisecond | Standard Deviation 21.35 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, post-dose | -0.85 Millisecond | Standard Deviation 7.62 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 15 | -5.10 Millisecond | Standard Deviation 19.64 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 35 | 2.90 Millisecond | Standard Deviation 16.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 35 | -1.21 Millisecond | Standard Deviation 5.58 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, pre-dose | -0.71 Millisecond | Standard Deviation 24.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 1, post-dose | 1.23 Millisecond | Standard Deviation 18.96 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 15 | -0.98 Millisecond | Standard Deviation 15.75 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 35 | 1.95 Millisecond | Standard Deviation 13.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 35 | -1.17 Millisecond | Standard Deviation 10.59 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 1, post-dose | 0.54 Millisecond | Standard Deviation 7.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 8 | 0.56 Millisecond | Standard Deviation 7.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 22 | -4.13 Millisecond | Standard Deviation 23.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, pre-dose | -1.28 Millisecond | Standard Deviation 6.8 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 22 | 0.15 Millisecond | Standard Deviation 12.31 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, post-dose | -0.03 Millisecond | Standard Deviation 6.62 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 22 | -1.00 Millisecond | Standard Deviation 5.43 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 1, post-dose | 3.49 Millisecond | Standard Deviation 18.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, pre-dose | 1.50 Millisecond | Standard Deviation 19.86 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 15 | -1.37 Millisecond | Standard Deviation 11.87 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 22 | -6.00 Millisecond | Standard Deviation 18.92 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, pre-dose | 3.48 Millisecond | Standard Deviation 20.88 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 35 | 0.63 Millisecond | Standard Deviation 26.55 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, post-dose | 4.35 Millisecond | Standard Deviation 24.7 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, post-dose | 1.88 Millisecond | Standard Deviation 15.35 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, post-dose | 0.83 Millisecond | Standard Deviation 19.86 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 1, post-dose | 3.37 Millisecond | Standard Deviation 18.91 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 8 | 4.17 Millisecond | Standard Deviation 20.65 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 15 | -0.78 Millisecond | Standard Deviation 12.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 15 | 0.68 Millisecond | Standard Deviation 19.64 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 35 | 5.12 Millisecond | Standard Deviation 26.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 8 | 0.68 Millisecond | Standard Deviation 13.49 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 1, post-dose | 0.32 Millisecond | Standard Deviation 9.96 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 8 | -2.46 Millisecond | Standard Deviation 14.66 |
| SRT2104 1.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, pre-dose | 3.70 Millisecond | Standard Deviation 13.45 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 22 | 0.28 Millisecond | Standard Deviation 9.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 15 | -1.03 Millisecond | Standard Deviation 12.96 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 8 | 1.45 Millisecond | Standard Deviation 25.9 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, pre-dose | -0.54 Millisecond | Standard Deviation 7.41 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 35 | 1.15 Millisecond | Standard Deviation 10.41 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 22 | -0.10 Millisecond | Standard Deviation 22.32 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 35 | -1.34 Millisecond | Standard Deviation 28.57 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 15 | 4.40 Millisecond | Standard Deviation 23.37 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 22 | -1.46 Millisecond | Standard Deviation 14.71 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 35 | 4.27 Millisecond | Standard Deviation 27.43 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 15 | 0.80 Millisecond | Standard Deviation 8.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 1, post-dose | -1.71 Millisecond | Standard Deviation 23.06 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 35 | 0.83 Millisecond | Standard Deviation 8.89 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 28, post-dose | 0.21 Millisecond | Standard Deviation 9.09 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 22 | 0.64 Millisecond | Standard Deviation 18.54 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, post-dose | 3.33 Millisecond | Standard Deviation 13.27 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, pre-dose | 1.00 Millisecond | Standard Deviation 18.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 15 | 1.53 Millisecond | Standard Deviation 19.98 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 1, post-dose | 1.57 Millisecond | Standard Deviation 11.91 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 8 | 0.85 Millisecond | Standard Deviation 10.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 28, post-dose | -1.28 Millisecond | Standard Deviation 24.6 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 28, pre-dose | 0.31 Millisecond | Standard Deviation 17.74 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, pre-dose | -4.67 Millisecond | Standard Deviation 19.3 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 8 | -2.98 Millisecond | Standard Deviation 25.8 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | PR interval, Day 8 | -3.63 Millisecond | Standard Deviation 15.56 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QT interval, Day 1, post-dose | 1.17 Millisecond | Standard Deviation 17.14 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QRS interval, Day 1, post-dose | 1.45 Millisecond | Standard Deviation 8.12 |
| SRT2104 2.0 g/Day | Change From Baseline in Electrocardiogram (ECG) Values Over Time | QTc interval, Day 28, post-dose | -4.44 Millisecond | Standard Deviation 20.43 |
Primary
Change From Baseline in Hematology Parameter of Hematocrit Over Time
Assessment for hematocrit was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 28 | -0.00 Ratio | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 8 | -0.00 Ratio | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 35 | -0.00 Ratio | Standard Deviation 0.03 |
| Placebo | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 15 | 0.00 Ratio | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 22 | 0.01 Ratio | Standard Deviation 0.05 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 28 | -0.01 Ratio | Standard Deviation 0.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 22 | 0.01 Ratio | Standard Deviation 0.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 15 | 0.00 Ratio | Standard Deviation 0.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 35 | -0.01 Ratio | Standard Deviation 0.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 8 | 0.00 Ratio | Standard Deviation 0.03 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 22 | -0.00 Ratio | Standard Deviation 0.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 8 | -0.00 Ratio | Standard Deviation 0.03 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 28 | -0.01 Ratio | Standard Deviation 0.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 35 | -0.01 Ratio | Standard Deviation 0.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 35 | -0.01 Ratio | Standard Deviation 0.03 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 8 | 0.00 Ratio | Standard Deviation 0.03 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 28 | -0.01 Ratio | Standard Deviation 0.04 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 22 | -0.00 Ratio | Standard Deviation 0.03 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 22 | -0.00 Ratio | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 28 | -0.01 Ratio | Standard Deviation 0.03 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 8 | 0.00 Ratio | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 35 | -0.01 Ratio | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hematocrit Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0.02 |
Primary
Change From Baseline in Hematology Parameter of Hemoglobin Over Time
Assessment for hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 28 | -0.43 Gram per liter | Standard Deviation 7.34 |
| Placebo | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 35 | -2.19 Gram per liter | Standard Deviation 8.37 |
| Placebo | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 15 | 0.31 Gram per liter | Standard Deviation 5.13 |
| Placebo | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 22 | -1.08 Gram per liter | Standard Deviation 5.87 |
| Placebo | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 8 | -0.75 Gram per liter | Standard Deviation 5.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 22 | 1.05 Gram per liter | Standard Deviation 10.71 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 35 | -2.33 Gram per liter | Standard Deviation 11.1 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 8 | 1.49 Gram per liter | Standard Deviation 9.28 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 15 | 1.09 Gram per liter | Standard Deviation 11.65 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 28 | -2.60 Gram per liter | Standard Deviation 11.34 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 22 | -0.57 Gram per liter | Standard Deviation 7.56 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 15 | -0.32 Gram per liter | Standard Deviation 7.21 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 8 | -0.03 Gram per liter | Standard Deviation 7.36 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 28 | -2.32 Gram per liter | Standard Deviation 7.83 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 35 | -3.50 Gram per liter | Standard Deviation 7.53 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 22 | -0.82 Gram per liter | Standard Deviation 9.7 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 8 | 0.47 Gram per liter | Standard Deviation 8.03 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 15 | -0.81 Gram per liter | Standard Deviation 8.25 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 28 | -2.58 Gram per liter | Standard Deviation 10.49 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 35 | -4.75 Gram per liter | Standard Deviation 9.87 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 35 | -3.08 Gram per liter | Standard Deviation 6.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 28 | -3.83 Gram per liter | Standard Deviation 6.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 22 | -0.05 Gram per liter | Standard Deviation 5.92 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 15 | 0.40 Gram per liter | Standard Deviation 6.7 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Hemoglobin Over Time | Day 8 | 1.44 Gram per liter | Standard Deviation 6.58 |
Primary
Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time
Assessment for mean corpuscular hemoglobin concentration was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 28 | -1.56 Gram hemoglobin per liter | Standard Deviation 8.08 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 8 | -1.43 Gram hemoglobin per liter | Standard Deviation 8.1 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 35 | -2.35 Gram hemoglobin per liter | Standard Deviation 7.81 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 15 | 0.59 Gram hemoglobin per liter | Standard Deviation 7.36 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 22 | -4.00 Gram hemoglobin per liter | Standard Deviation 21.58 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 28 | 1.85 Gram hemoglobin per liter | Standard Deviation 8.34 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 22 | -1.25 Gram hemoglobin per liter | Standard Deviation 8.33 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 15 | 0.31 Gram hemoglobin per liter | Standard Deviation 8.22 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 35 | 0.32 Gram hemoglobin per liter | Standard Deviation 11.69 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 8 | 0.00 Gram hemoglobin per liter | Standard Deviation 7.56 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 22 | 0.25 Gram hemoglobin per liter | Standard Deviation 9.47 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 8 | 0.77 Gram hemoglobin per liter | Standard Deviation 8.39 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 15 | 2.16 Gram hemoglobin per liter | Standard Deviation 7.5 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 28 | 1.47 Gram hemoglobin per liter | Standard Deviation 6.57 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 35 | -0.81 Gram hemoglobin per liter | Standard Deviation 7.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 35 | 0.32 Gram hemoglobin per liter | Standard Deviation 12.51 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 8 | 0.56 Gram hemoglobin per liter | Standard Deviation 9.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 28 | -0.59 Gram hemoglobin per liter | Standard Deviation 12.78 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 22 | -2.29 Gram hemoglobin per liter | Standard Deviation 11.65 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 15 | -0.63 Gram hemoglobin per liter | Standard Deviation 11.34 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 22 | 1.56 Gram hemoglobin per liter | Standard Deviation 7.67 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 28 | 0.00 Gram hemoglobin per liter | Standard Deviation 8.77 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 8 | 3.33 Gram hemoglobin per liter | Standard Deviation 9.24 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 35 | -1.54 Gram hemoglobin per liter | Standard Deviation 7.32 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Concentration Over Time | Day 15 | 0.31 Gram hemoglobin per liter | Standard Deviation 8.61 |
Primary
Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time
Assessment for mean corpuscular hemoglobin was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 28 | 0.10 Picogram per cell | Standard Deviation 0.74 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 8 | 0.00 Picogram per cell | Standard Deviation 0.72 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 35 | 0.11 Picogram per cell | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 15 | 0.03 Picogram per cell | Standard Deviation 0.58 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 22 | -0.24 Picogram per cell | Standard Deviation 1.79 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 28 | 0.11 Picogram per cell | Standard Deviation 0.96 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 22 | 0.14 Picogram per cell | Standard Deviation 0.79 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 15 | 0.23 Picogram per cell | Standard Deviation 1.14 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 35 | 0.05 Picogram per cell | Standard Deviation 1.36 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 8 | 0.15 Picogram per cell | Standard Deviation 0.79 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 22 | 0.14 Picogram per cell | Standard Deviation 0.65 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 8 | 0.23 Picogram per cell | Standard Deviation 0.62 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 15 | 0.27 Picogram per cell | Standard Deviation 0.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 28 | 0.39 Picogram per cell | Standard Deviation 0.67 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 35 | 0.38 Picogram per cell | Standard Deviation 0.66 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 35 | -0.11 Picogram per cell | Standard Deviation 1.74 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 8 | -0.16 Picogram per cell | Standard Deviation 0.82 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 28 | 0.03 Picogram per cell | Standard Deviation 0.94 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 22 | -0.18 Picogram per cell | Standard Deviation 0.9 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 15 | -0.03 Picogram per cell | Standard Deviation 0.81 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 22 | 0.10 Picogram per cell | Standard Deviation 0.64 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 28 | 0.00 Picogram per cell | Standard Deviation 0.6 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 8 | 0.17 Picogram per cell | Standard Deviation 0.67 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 35 | 0.08 Picogram per cell | Standard Deviation 0.73 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Hemoglobin Over Time | Day 15 | -0.08 Picogram per cell | Standard Deviation 0.53 |
Primary
Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time
Assessment for mean corpuscular volume was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 28 | 0.81 Femtoliter | Standard Deviation 1.89 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 8 | 0.20 Femtoliter | Standard Deviation 1.21 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 35 | 1.00 Femtoliter | Standard Deviation 1.74 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 15 | 0.29 Femtoliter | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 22 | 0.17 Femtoliter | Standard Deviation 1.98 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 15 | 0.69 Femtoliter | Standard Deviation 3.35 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 22 | 0.59 Femtoliter | Standard Deviation 1.7 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 8 | 0.28 Femtoliter | Standard Deviation 1.77 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 28 | -0.19 Femtoliter | Standard Deviation 2.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 35 | 0.74 Femtoliter | Standard Deviation 3.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 15 | 0.11 Femtoliter | Standard Deviation 1.54 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 8 | 0.18 Femtoliter | Standard Deviation 1.68 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 22 | 0.05 Femtoliter | Standard Deviation 1.72 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 28 | 0.29 Femtoliter | Standard Deviation 1.17 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 35 | 0.73 Femtoliter | Standard Deviation 1.63 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 35 | -0.71 Femtoliter | Standard Deviation 4.27 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 8 | -0.33 Femtoliter | Standard Deviation 2.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 28 | 0.29 Femtoliter | Standard Deviation 2.7 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 22 | 0.03 Femtoliter | Standard Deviation 2.27 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 15 | -0.06 Femtoliter | Standard Deviation 2.71 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 22 | 0.13 Femtoliter | Standard Deviation 1.66 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 28 | 0.22 Femtoliter | Standard Deviation 1.72 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 8 | -0.17 Femtoliter | Standard Deviation 1.53 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 35 | 0.77 Femtoliter | Standard Deviation 1.7 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Mean Corpuscular Volume Over Time | Day 15 | -0.03 Femtoliter | Standard Deviation 1.45 |
Primary
Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time
Assessment for RBC count was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 28 | -0.02 Trillion cells per liter | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 8 | -0.02 Trillion cells per liter | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 35 | -0.08 Trillion cells per liter | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 15 | 0.01 Trillion cells per liter | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 22 | 0.04 Trillion cells per liter | Standard Deviation 0.48 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 28 | -0.10 Trillion cells per liter | Standard Deviation 0.38 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 22 | 0.03 Trillion cells per liter | Standard Deviation 0.36 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 15 | 0.02 Trillion cells per liter | Standard Deviation 0.39 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 35 | -0.10 Trillion cells per liter | Standard Deviation 0.35 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 8 | 0.03 Trillion cells per liter | Standard Deviation 0.31 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 22 | -0.04 Trillion cells per liter | Standard Deviation 0.22 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 8 | -0.02 Trillion cells per liter | Standard Deviation 0.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 15 | -0.04 Trillion cells per liter | Standard Deviation 0.22 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 28 | -0.11 Trillion cells per liter | Standard Deviation 0.23 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 35 | -0.14 Trillion cells per liter | Standard Deviation 0.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 35 | -0.13 Trillion cells per liter | Standard Deviation 0.41 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 8 | 0.03 Trillion cells per liter | Standard Deviation 0.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 28 | -0.09 Trillion cells per liter | Standard Deviation 0.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 22 | -0.01 Trillion cells per liter | Standard Deviation 0.27 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 15 | -0.03 Trillion cells per liter | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 22 | -0.01 Trillion cells per liter | Standard Deviation 0.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 28 | -0.12 Trillion cells per liter | Standard Deviation 0.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 8 | 0.03 Trillion cells per liter | Standard Deviation 0.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 35 | -0.12 Trillion cells per liter | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameter of Red Blood Cell (RBC) Count Over Time | Day 15 | 0.02 Trillion cells per liter | Standard Deviation 0.24 |
Primary
Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time
Assessment for basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and white blood cell (WBC) count were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 28 | 0.01 Giga cells per liter | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 22 | -0.07 Giga cells per liter | Standard Deviation 0.82 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 15 | 15.19 Giga cells per liter | Standard Deviation 41.9 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 15 | 0.02 Giga cells per liter | Standard Deviation 0.12 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 8 | 0.01 Giga cells per liter | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 22 | 0.01 Giga cells per liter | Standard Deviation 0.01 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 8 | 6.37 Giga cells per liter | Standard Deviation 35.76 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 15 | -0.04 Giga cells per liter | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 8 | 0.01 Giga cells per liter | Standard Deviation 0.14 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 15 | 0.15 Giga cells per liter | Standard Deviation 0.83 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 28 | -3.05 Giga cells per liter | Standard Deviation 33.65 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 15 | 0.35 Giga cells per liter | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 22 | -0.01 Giga cells per liter | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 28 | 0.12 Giga cells per liter | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 28 | 0.08 Giga cells per liter | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 35 | 10.89 Giga cells per liter | Standard Deviation 31.69 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 22 | 0.05 Giga cells per liter | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 8 | 0.04 Giga cells per liter | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 35 | 0.23 Giga cells per liter | Standard Deviation 1.29 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 28 | -0.05 Giga cells per liter | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 35 | -0.02 Giga cells per liter | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 15 | 0.01 Giga cells per liter | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 22 | 9.28 Giga cells per liter | Standard Deviation 33.79 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 28 | 0.00 Giga cells per liter | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 8 | 0.15 Giga cells per liter | Standard Deviation 1.36 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 8 | 0.12 Giga cells per liter | Standard Deviation 0.44 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 35 | 0.16 Giga cells per liter | Standard Deviation 0.45 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 22 | 0.15 Giga cells per liter | Standard Deviation 0.92 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 8 | 0.01 Giga cells per liter | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 35 | 0.05 Giga cells per liter | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 15 | 0.22 Giga cells per liter | Standard Deviation 0.52 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 28 | 0.05 Giga cells per liter | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count Day 35 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 35 | 0.03 Giga cells per liter | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 22 | 0.14 Giga cells per liter | Standard Deviation 0.46 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 15 | 0.01 Giga cells per liter | Standard Deviation 0.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 8 | 0.37 Giga cells per liter | Standard Deviation 1.29 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 8 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 28 | -0.03 Giga cells per liter | Standard Deviation 0.49 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 15 | 13.45 Giga cells per liter | Standard Deviation 39.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 8 | 0.01 Giga cells per liter | Standard Deviation 0.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 35 | 0.15 Giga cells per liter | Standard Deviation 0.58 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 22 | 0.75 Giga cells per liter | Standard Deviation 1.64 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 28 | 3.81 Giga cells per liter | Standard Deviation 45 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 8 | 0.02 Giga cells per liter | Standard Deviation 0.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 28 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 15 | 0.02 Giga cells per liter | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 35 | 0.02 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 22 | 9.49 Giga cells per liter | Standard Deviation 42.29 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 22 | 0.05 Giga cells per liter | Standard Deviation 0.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 28 | -0.03 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 15 | 0.01 Giga cells per liter | Standard Deviation 0.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count Day 35 | 0.01 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 35 | 0.29 Giga cells per liter | Standard Deviation 1.53 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 22 | 0.56 Giga cells per liter | Standard Deviation 1.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 15 | 0.67 Giga cells per liter | Standard Deviation 1.36 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 22 | 0.17 Giga cells per liter | Standard Deviation 0.54 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 22 | 0.01 Giga cells per liter | Standard Deviation 0.1 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 28 | 0.21 Giga cells per liter | Standard Deviation 1.56 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 28 | 0.35 Giga cells per liter | Standard Deviation 1.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 15 | 0.55 Giga cells per liter | Standard Deviation 1.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 8 | 0.43 Giga cells per liter | Standard Deviation 1.66 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 35 | -0.01 Giga cells per liter | Standard Deviation 0.14 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 22 | 0.01 Giga cells per liter | Standard Deviation 0.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 28 | 0.02 Giga cells per liter | Standard Deviation 0.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 8 | 0.20 Giga cells per liter | Standard Deviation 0.59 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 8 | 4.03 Giga cells per liter | Standard Deviation 40.19 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 15 | 0.10 Giga cells per liter | Standard Deviation 0.58 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 35 | 0.29 Giga cells per liter | Standard Deviation 1.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 35 | 6.27 Giga cells per liter | Standard Deviation 42.88 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 15 | 0.04 Giga cells per liter | Standard Deviation 0.12 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 35 | 0.00 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 15 | 0.01 Giga cells per liter | Standard Deviation 0.03 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 8 | 0.11 Giga cells per liter | Standard Deviation 1.05 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 35 | 0.34 Giga cells per liter | Standard Deviation 0.9 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 15 | 0.27 Giga cells per liter | Standard Deviation 0.88 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 22 | 0.58 Giga cells per liter | Standard Deviation 0.94 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 22 | 0.31 Giga cells per liter | Standard Deviation 0.71 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 8 | 2.34 Giga cells per liter | Standard Deviation 26.94 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 28 | -0.18 Giga cells per liter | Standard Deviation 0.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 35 | 0.09 Giga cells per liter | Standard Deviation 0.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 22 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 28 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count Day 35 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 15 | 0.59 Giga cells per liter | Standard Deviation 1.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 8 | 0.03 Giga cells per liter | Standard Deviation 0.17 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 28 | 0.03 Giga cells per liter | Standard Deviation 1.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 15 | 0.04 Giga cells per liter | Standard Deviation 0.28 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 22 | 0.01 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 8 | 0.37 Giga cells per liter | Standard Deviation 1.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 28 | 0.02 Giga cells per liter | Standard Deviation 0.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 35 | 0.03 Giga cells per liter | Standard Deviation 0.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 8 | 0.10 Giga cells per liter | Standard Deviation 0.46 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 35 | 11.58 Giga cells per liter | Standard Deviation 26.85 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 15 | 0.16 Giga cells per liter | Standard Deviation 0.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 22 | 0.22 Giga cells per liter | Standard Deviation 0.43 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 28 | 0.49 Giga cells per liter | Standard Deviation 0.47 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 8 | 0.00 Giga cells per liter | Standard Deviation 0.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 28 | 7.11 Giga cells per liter | Standard Deviation 21.05 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 35 | 0.18 Giga cells per liter | Standard Deviation 0.43 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 8 | 0.03 Giga cells per liter | Standard Deviation 0.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 22 | 16.42 Giga cells per liter | Standard Deviation 27.73 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 22 | 0.01 Giga cells per liter | Standard Deviation 0.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 28 | -0.00 Giga cells per liter | Standard Deviation 0.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 15 | 13.10 Giga cells per liter | Standard Deviation 28.86 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 8 | 0.04 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 15 | 0.11 Giga cells per liter | Standard Deviation 0.46 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 8 | 12.14 Giga cells per liter | Standard Deviation 28.82 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 15 | 15.40 Giga cells per liter | Standard Deviation 30.99 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 35 | 0.26 Giga cells per liter | Standard Deviation 1.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 8 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 15 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 22 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 28 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count Day 35 | 0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 8 | -0.01 Giga cells per liter | Standard Deviation 0.09 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 15 | 0.01 Giga cells per liter | Standard Deviation 0.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 22 | 0.02 Giga cells per liter | Standard Deviation 0.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 28 | -0.00 Giga cells per liter | Standard Deviation 0.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 35 | -0.02 Giga cells per liter | Standard Deviation 0.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 8 | 0.12 Giga cells per liter | Standard Deviation 0.53 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 22 | -0.00 Giga cells per liter | Standard Deviation 0.43 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 28 | -0.02 Giga cells per liter | Standard Deviation 0.47 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 35 | 0.06 Giga cells per liter | Standard Deviation 0.46 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 15 | 0.04 Giga cells per liter | Standard Deviation 0.14 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 22 | 0.00 Giga cells per liter | Standard Deviation 0.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 28 | -0.01 Giga cells per liter | Standard Deviation 0.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 35 | -0.01 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 8 | 0.10 Giga cells per liter | Standard Deviation 1.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 15 | 0.31 Giga cells per liter | Standard Deviation 1.27 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 22 | 0.14 Giga cells per liter | Standard Deviation 1.38 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 28 | 0.19 Giga cells per liter | Standard Deviation 1.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 35 | 0.28 Giga cells per liter | Standard Deviation 1.13 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 22 | 19.70 Giga cells per liter | Standard Deviation 29.51 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 28 | 5.22 Giga cells per liter | Standard Deviation 34.65 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 35 | 20.65 Giga cells per liter | Standard Deviation 35.89 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 8 | 0.09 Giga cells per liter | Standard Deviation 1.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 15 | 0.44 Giga cells per liter | Standard Deviation 1.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 22 | 0.18 Giga cells per liter | Standard Deviation 1.62 |
| SRT2104 1.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 28 | 0.02 Giga cells per liter | Standard Deviation 1.41 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 22 | 0.05 Giga cells per liter | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 15 | 0.04 Giga cells per liter | Standard Deviation 0.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 8 | 0.05 Giga cells per liter | Standard Deviation 0.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 8 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 35 | 0.10 Giga cells per liter | Standard Deviation 0.57 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 28 | -0.07 Giga cells per liter | Standard Deviation 0.47 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 28 | 0.20 Giga cells per liter | Standard Deviation 1.46 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 28 | 8.73 Giga cells per liter | Standard Deviation 43.33 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 22 | 0.04 Giga cells per liter | Standard Deviation 0.36 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 15 | 0.05 Giga cells per liter | Standard Deviation 0.46 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Lymphocyte count, Day 8 | 0.20 Giga cells per liter | Standard Deviation 0.58 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 22 | 4.49 Giga cells per liter | Standard Deviation 30.38 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 35 | 15.75 Giga cells per liter | Standard Deviation 37.58 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 35 | 0.05 Giga cells per liter | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 28 | 0.02 Giga cells per liter | Standard Deviation 0.17 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 22 | 0.03 Giga cells per liter | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 35 | 0.66 Giga cells per liter | Standard Deviation 1.68 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 8 | 0.22 Giga cells per liter | Standard Deviation 1.49 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 15 | -0.03 Giga cells per liter | Standard Deviation 0.12 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Eosinophil count, Day 8 | 0.01 Giga cells per liter | Standard Deviation 0.14 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count Day 35 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 15 | 7.73 Giga cells per liter | Standard Deviation 28.91 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 15 | 0.49 Giga cells per liter | Standard Deviation 1.6 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 28 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 22 | -0.01 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Baseophil count, Day 15 | -0.00 Giga cells per liter | Standard Deviation 0.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 8 | 0.03 Giga cells per liter | Standard Deviation 1.11 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | WBC count, Day 22 | 0.31 Giga cells per liter | Standard Deviation 1.76 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 35 | 0.55 Giga cells per liter | Standard Deviation 1.4 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 28 | 0.26 Giga cells per liter | Standard Deviation 1.28 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 22 | 0.20 Giga cells per liter | Standard Deviation 1.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Platelet count, Day 8 | 5.75 Giga cells per liter | Standard Deviation 23.95 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Neutrophil count, Day 15 | 0.46 Giga cells per liter | Standard Deviation 1.4 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 35 | 0.02 Giga cells per liter | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Hematology Parameters of Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet and White Blood Cell (WBC) Count Over Time | Monocyte count, Day 28 | 0.00 Giga cells per liter | Standard Deviation 0.17 |
Primary
Change From Baseline in Urinalysis Parameter of pH Over Time
Urinalysis parameter included urine pH. pH was calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. The assessment was performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 35 | 0.06 Points on scale | Standard Deviation 0.48 |
| Placebo | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 8 | 0.05 Points on scale | Standard Deviation 0.34 |
| Placebo | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 28 | 0.28 Points on scale | Standard Deviation 0.66 |
| Placebo | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 15 | 0.05 Points on scale | Standard Deviation 0.35 |
| Placebo | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 22 | 0.14 Points on scale | Standard Deviation 0.41 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 35 | -0.15 Points on scale | Standard Deviation 0.37 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 22 | -0.03 Points on scale | Standard Deviation 0.5 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 15 | -0.04 Points on scale | Standard Deviation 0.45 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 28 | -0.09 Points on scale | Standard Deviation 0.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 8 | -0.05 Points on scale | Standard Deviation 0.38 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 22 | 0.01 Points on scale | Standard Deviation 0.55 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 8 | -0.02 Points on scale | Standard Deviation 0.35 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 15 | -0.05 Points on scale | Standard Deviation 0.57 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 35 | -0.12 Points on scale | Standard Deviation 0.55 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 28 | 0.00 Points on scale | Standard Deviation 0.59 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 35 | 0.01 Points on scale | Standard Deviation 0.38 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 8 | 0.00 Points on scale | Standard Deviation 0.43 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 15 | 0.11 Points on scale | Standard Deviation 0.47 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 22 | 0.05 Points on scale | Standard Deviation 0.4 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 28 | 0.03 Points on scale | Standard Deviation 0.37 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 8 | 0.10 Points on scale | Standard Deviation 0.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 15 | 0.08 Points on scale | Standard Deviation 0.62 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 22 | -0.03 Points on scale | Standard Deviation 0.48 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 28 | 0.04 Points on scale | Standard Deviation 0.63 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of pH Over Time | Day 35 | 0.07 Points on scale | Standard Deviation 0.52 |
Primary
Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time
Urinary specific gravity is a measure of the concentration of solutes in urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. The assessments were performed on Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 28 | 0.00 Ratio | Standard Deviation 0.01 |
| Placebo | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 8 | -0.00 Ratio | Standard Deviation 0.01 |
| Placebo | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 35 | -0.00 Ratio | Standard Deviation 0.01 |
| Placebo | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0.01 |
| Placebo | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 22 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 28 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 22 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 35 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 8 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 22 | 0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 8 | 0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 28 | 0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 35 | 0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 35 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 8 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 28 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 22 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 15 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 22 | 0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 28 | 0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 8 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 35 | -0.00 Ratio | Standard Deviation 0.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Urinalysis Parameter of Specific Gravity Over Time | Day 15 | 0.00 Ratio | Standard Deviation 0.01 |
Primary
Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time
Vital sign assessment of HR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.
Time frame: Baseline (Day 1, pre-dose) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 27 | -1.70 Beats per minute (bpm) | Standard Deviation 6.94 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 5 minutes | 0.88 Beats per minute (bpm) | Standard Deviation 6.9 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, pre-dose | 0.79 Beats per minute (bpm) | Standard Deviation 5.72 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 12 hour | -1.72 Beats per minute (bpm) | Standard Deviation 7 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, pre-dose | 0.44 Beats per minute (bpm) | Standard Deviation 7.1 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 1 hour | -0.16 Beats per minute (bpm) | Standard Deviation 5.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 30 minutes | 0.59 Beats per minute (bpm) | Standard Deviation 5.92 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 5 minutes | -0.05 Beats per minute (bpm) | Standard Deviation 6.69 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 1 hour | 0.47 Beats per minute (bpm) | Standard Deviation 4.99 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 35 | -0.30 Beats per minute (bpm) | Standard Deviation 7.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 8 hour | -0.70 Beats per minute (bpm) | Standard Deviation 6 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 8 hour | -0.40 Beats per minute (bpm) | Standard Deviation 7.47 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 3 hour | -0.12 Beats per minute (bpm) | Standard Deviation 5.39 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 15 minutes | -0.02 Beats per minute (bpm) | Standard Deviation 5.82 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 4 hour | -0.91 Beats per minute (bpm) | Standard Deviation 7.33 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 30 minutes | 0.05 Beats per minute (bpm) | Standard Deviation 5.99 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 3 hour | -0.55 Beats per minute (bpm) | Standard Deviation 6.56 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 1 hour | 0.21 Beats per minute (bpm) | Standard Deviation 6.16 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 24 hour | -1.58 Beats per minute (bpm) | Standard Deviation 7.43 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 2 hour | -0.23 Beats per minute (bpm) | Standard Deviation 5.63 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 2 hour | -1.40 Beats per minute (bpm) | Standard Deviation 6.93 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 1 hour | -0.44 Beats per minute (bpm) | Standard Deviation 6.55 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 30 minutes | -0.60 Beats per minute (bpm) | Standard Deviation 6.97 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 4 hour | -1.37 Beats per minute (bpm) | Standard Deviation 5.94 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 15 minutes | -0.67 Beats per minute (bpm) | Standard Deviation 7.61 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 12 hour | -1.05 Beats per minute (bpm) | Standard Deviation 6.35 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 24 hour | 0.12 Beats per minute (bpm) | Standard Deviation 5.49 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 5 minutes | 0.67 Beats per minute (bpm) | Standard Deviation 5.15 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, pre-dose | -1.67 Beats per minute (bpm) | Standard Deviation 6.92 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, pre-dose | 0.14 Beats per minute (bpm) | Standard Deviation 6.11 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 5 minutes | 1.33 Beats per minute (bpm) | Standard Deviation 5.59 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, pre-dose | -0.35 Beats per minute (bpm) | Standard Deviation 7.53 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 1 hour | -0.21 Beats per minute (bpm) | Standard Deviation 6.05 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 30 minutes | 0.47 Beats per minute (bpm) | Standard Deviation 4.97 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 30 minutes | -0.72 Beats per minute (bpm) | Standard Deviation 6.01 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 30 minutes | 0.41 Beats per minute (bpm) | Standard Deviation 7.02 |
| Placebo | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 1 hour | -0.38 Beats per minute (bpm) | Standard Deviation 4.5 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 2 hour | -3.16 Beats per minute (bpm) | Standard Deviation 6.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 1 hour | -1.03 Beats per minute (bpm) | Standard Deviation 8.11 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, pre-dose | -1.33 Beats per minute (bpm) | Standard Deviation 8.21 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 24 hour | -0.40 Beats per minute (bpm) | Standard Deviation 5.57 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, pre-dose | -0.84 Beats per minute (bpm) | Standard Deviation 6.74 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 5 minutes | -0.59 Beats per minute (bpm) | Standard Deviation 7.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 5 minutes | 1.00 Beats per minute (bpm) | Standard Deviation 5.81 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 1 hour | -0.81 Beats per minute (bpm) | Standard Deviation 7.5 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 5 minutes | -0.56 Beats per minute (bpm) | Standard Deviation 6.47 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 3 hour | 0.07 Beats per minute (bpm) | Standard Deviation 6.25 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 30 minutes | -0.24 Beats per minute (bpm) | Standard Deviation 8.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 12 hour | -2.05 Beats per minute (bpm) | Standard Deviation 6.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 30 minutes | -0.15 Beats per minute (bpm) | Standard Deviation 6.78 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 8 hour | -2.14 Beats per minute (bpm) | Standard Deviation 6.29 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 5 minutes | -0.55 Beats per minute (bpm) | Standard Deviation 8.34 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 30 minutes | -1.84 Beats per minute (bpm) | Standard Deviation 6.99 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 30 minutes | -1.08 Beats per minute (bpm) | Standard Deviation 7.69 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 1 hour | -0.35 Beats per minute (bpm) | Standard Deviation 6.91 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 1 hour | 0.18 Beats per minute (bpm) | Standard Deviation 5.85 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, pre-dose | -0.53 Beats per minute (bpm) | Standard Deviation 8.05 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, pre-dose | 0.30 Beats per minute (bpm) | Standard Deviation 6.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 1 hour | -1.76 Beats per minute (bpm) | Standard Deviation 7.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 4 hour | -0.53 Beats per minute (bpm) | Standard Deviation 6.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 30 minutes | 0.28 Beats per minute (bpm) | Standard Deviation 5.8 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 4 hour | -2.22 Beats per minute (bpm) | Standard Deviation 6.94 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 15 minutes | -1.11 Beats per minute (bpm) | Standard Deviation 7.44 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 8 hour | -0.79 Beats per minute (bpm) | Standard Deviation 4.29 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 15 minutes | 1.02 Beats per minute (bpm) | Standard Deviation 5.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 30 minutes | 1.12 Beats per minute (bpm) | Standard Deviation 5.55 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 2 hour | 0.09 Beats per minute (bpm) | Standard Deviation 5.95 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 27 | -1.19 Beats per minute (bpm) | Standard Deviation 8.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 24 hour | -1.50 Beats per minute (bpm) | Standard Deviation 7.26 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 3 hour | -1.97 Beats per minute (bpm) | Standard Deviation 6.72 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 12 hour | -1.05 Beats per minute (bpm) | Standard Deviation 4.77 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 35 | -1.90 Beats per minute (bpm) | Standard Deviation 6.8 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 1 hour | 0.33 Beats per minute (bpm) | Standard Deviation 5.84 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, pre-dose | -1.95 Beats per minute (bpm) | Standard Deviation 6.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, pre-dose | -1.26 Beats per minute (bpm) | Standard Deviation 5.44 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 8 hour | -0.72 Beats per minute (bpm) | Standard Deviation 5.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 1 hour | -1.13 Beats per minute (bpm) | Standard Deviation 6.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 5 minutes | 1.12 Beats per minute (bpm) | Standard Deviation 8.94 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 30 minutes | -0.12 Beats per minute (bpm) | Standard Deviation 7.3 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 1 hour | -1.20 Beats per minute (bpm) | Standard Deviation 6.75 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 15 minutes | 0.23 Beats per minute (bpm) | Standard Deviation 5.08 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 30 minutes | 0.47 Beats per minute (bpm) | Standard Deviation 6.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 1 hour | -0.35 Beats per minute (bpm) | Standard Deviation 6.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 2 hour | -1.16 Beats per minute (bpm) | Standard Deviation 5.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 3 hour | -1.19 Beats per minute (bpm) | Standard Deviation 6.5 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 4 hour | -0.40 Beats per minute (bpm) | Standard Deviation 6.81 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 12 hour | -0.72 Beats per minute (bpm) | Standard Deviation 6.03 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 24 hour | 0.14 Beats per minute (bpm) | Standard Deviation 5.09 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, pre-dose | 0.14 Beats per minute (bpm) | Standard Deviation 5.02 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 5 minutes | -0.12 Beats per minute (bpm) | Standard Deviation 5.69 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 30 minutes | -0.08 Beats per minute (bpm) | Standard Deviation 6.07 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, pre-dose | 1.53 Beats per minute (bpm) | Standard Deviation 8.69 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 30 minutes | -1.11 Beats per minute (bpm) | Standard Deviation 7.51 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 1 hour | -1.26 Beats per minute (bpm) | Standard Deviation 6.73 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, pre-dose | 0.23 Beats per minute (bpm) | Standard Deviation 6.79 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 5 minutes | 0.43 Beats per minute (bpm) | Standard Deviation 8.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 30 minutes | -0.49 Beats per minute (bpm) | Standard Deviation 8.42 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 1 hour | -1.46 Beats per minute (bpm) | Standard Deviation 7.08 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, pre-dose | 1.33 Beats per minute (bpm) | Standard Deviation 7.89 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 5 minutes | 0.88 Beats per minute (bpm) | Standard Deviation 8.5 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 30 minutes | 0.05 Beats per minute (bpm) | Standard Deviation 8.33 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 1 hour | 0.46 Beats per minute (bpm) | Standard Deviation 7.45 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 27 | -1.83 Beats per minute (bpm) | Standard Deviation 6.58 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 15 minutes | -0.50 Beats per minute (bpm) | Standard Deviation 6.95 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 2 hour | -1.20 Beats per minute (bpm) | Standard Deviation 6.55 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 3 hour | -1.46 Beats per minute (bpm) | Standard Deviation 7.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 4 hour | -1.24 Beats per minute (bpm) | Standard Deviation 6.4 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 8 hour | -1.10 Beats per minute (bpm) | Standard Deviation 6.87 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 12 hour | -2.02 Beats per minute (bpm) | Standard Deviation 7.82 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 24 hour | -0.60 Beats per minute (bpm) | Standard Deviation 5.49 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 35 | -0.56 Beats per minute (bpm) | Standard Deviation 6.62 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 1 hour | -1.18 Beats per minute (bpm) | Standard Deviation 9.58 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, pre-dose | 0.15 Beats per minute (bpm) | Standard Deviation 7.8 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, pre-dose | -0.50 Beats per minute (bpm) | Standard Deviation 10.19 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 1 hour | -1.29 Beats per minute (bpm) | Standard Deviation 6.3 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 5 minutes | -0.10 Beats per minute (bpm) | Standard Deviation 9.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 30 minutes | -0.76 Beats per minute (bpm) | Standard Deviation 5.61 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 12 hour | -0.20 Beats per minute (bpm) | Standard Deviation 8.29 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 30 minutes | 0.53 Beats per minute (bpm) | Standard Deviation 9.53 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 5 minutes | 0.67 Beats per minute (bpm) | Standard Deviation 5.85 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 1 hour | 0.28 Beats per minute (bpm) | Standard Deviation 9.25 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, pre-dose | -0.14 Beats per minute (bpm) | Standard Deviation 4.95 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 12 hour | -1.38 Beats per minute (bpm) | Standard Deviation 5.58 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 27 | -0.75 Beats per minute (bpm) | Standard Deviation 8.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 24 hour | -0.19 Beats per minute (bpm) | Standard Deviation 5.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 15 minutes | 1.21 Beats per minute (bpm) | Standard Deviation 6.32 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, pre-dose | -0.73 Beats per minute (bpm) | Standard Deviation 9.6 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 4 hour | -1.81 Beats per minute (bpm) | Standard Deviation 5.64 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 8 hour | -2.14 Beats per minute (bpm) | Standard Deviation 5.26 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 15 minutes | -0.03 Beats per minute (bpm) | Standard Deviation 10.28 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 3 hour | 0.12 Beats per minute (bpm) | Standard Deviation 6.83 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 2 hour | -1.19 Beats per minute (bpm) | Standard Deviation 5.56 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 35 | -3.15 Beats per minute (bpm) | Standard Deviation 8.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 2 hour | -0.65 Beats per minute (bpm) | Standard Deviation 9.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 30 minutes | 1.12 Beats per minute (bpm) | Standard Deviation 6.06 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 24 hour | -1.33 Beats per minute (bpm) | Standard Deviation 7.91 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 3 hour | -1.53 Beats per minute (bpm) | Standard Deviation 8.71 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 4 hour | -1.93 Beats per minute (bpm) | Standard Deviation 9.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 1 hour | -0.73 Beats per minute (bpm) | Standard Deviation 8.33 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 30 minutes | -0.43 Beats per minute (bpm) | Standard Deviation 9.47 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 1 hour | -0.93 Beats per minute (bpm) | Standard Deviation 7.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 1 hour | -0.48 Beats per minute (bpm) | Standard Deviation 7.19 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, pre-dose | -1.10 Beats per minute (bpm) | Standard Deviation 8.42 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 30 minutes | 0.30 Beats per minute (bpm) | Standard Deviation 8.46 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 8 hour | -1.63 Beats per minute (bpm) | Standard Deviation 7.88 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 5 minutes | -1.17 Beats per minute (bpm) | Standard Deviation 8.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 30 minutes | -1.68 Beats per minute (bpm) | Standard Deviation 8.3 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 5 minutes | -0.07 Beats per minute (bpm) | Standard Deviation 8.13 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 30 minutes | 0.26 Beats per minute (bpm) | Standard Deviation 5.73 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 1 hour | 0.13 Beats per minute (bpm) | Standard Deviation 5.74 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 2 hour | 0.45 Beats per minute (bpm) | Standard Deviation 5.55 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 1 hour | 1.35 Beats per minute (bpm) | Standard Deviation 4.92 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 24 hour | 0.64 Beats per minute (bpm) | Standard Deviation 5.78 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 1 hour | 0.69 Beats per minute (bpm) | Standard Deviation 6.55 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, pre-dose | 1.36 Beats per minute (bpm) | Standard Deviation 6.47 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 30 minutes | 1.03 Beats per minute (bpm) | Standard Deviation 4.7 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 35 | 0.56 Beats per minute (bpm) | Standard Deviation 5.96 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 1 hour | 0.43 Beats per minute (bpm) | Standard Deviation 4.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 5 minutes | 0.62 Beats per minute (bpm) | Standard Deviation 6.74 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 1 hour | 1.71 Beats per minute (bpm) | Standard Deviation 6.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, 5 minutes | 1.14 Beats per minute (bpm) | Standard Deviation 5.34 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 30 minutes | 0.82 Beats per minute (bpm) | Standard Deviation 6.08 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 2 hour | 0.21 Beats per minute (bpm) | Standard Deviation 6.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 30 minutes | 0.51 Beats per minute (bpm) | Standard Deviation 6.42 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 30 minutes | 0.26 Beats per minute (bpm) | Standard Deviation 5.4 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 2, pre-dose | 0.81 Beats per minute (bpm) | Standard Deviation 5.61 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 12 hour | 0.54 Beats per minute (bpm) | Standard Deviation 7.57 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, 5 minutes | 0.68 Beats per minute (bpm) | Standard Deviation 6.36 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, 1 hour | 0.03 Beats per minute (bpm) | Standard Deviation 7.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 5 minutes | 1.85 Beats per minute (bpm) | Standard Deviation 6.31 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 15, pre-dose | -0.43 Beats per minute (bpm) | Standard Deviation 6.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 3 hour | 0.36 Beats per minute (bpm) | Standard Deviation 7.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 27 | -0.10 Beats per minute (bpm) | Standard Deviation 5.91 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 15 minutes | 1.60 Beats per minute (bpm) | Standard Deviation 4.47 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 12 hour | 0.45 Beats per minute (bpm) | Standard Deviation 6.66 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 24 hour | -0.92 Beats per minute (bpm) | Standard Deviation 6.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 4 hour | 0.05 Beats per minute (bpm) | Standard Deviation 6.03 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, pre-dose | -0.67 Beats per minute (bpm) | Standard Deviation 5.89 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 8 hour | 0.95 Beats per minute (bpm) | Standard Deviation 5.71 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 8, 30 minutes | 1.66 Beats per minute (bpm) | Standard Deviation 5.56 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 4 hour | 0.67 Beats per minute (bpm) | Standard Deviation 7.19 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 8 hour | 0.05 Beats per minute (bpm) | Standard Deviation 7.42 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 28, 15 minutes | 0.31 Beats per minute (bpm) | Standard Deviation 5.66 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 1, 3 hour | 0.19 Beats per minute (bpm) | Standard Deviation 5.71 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Heart Rate (HR) Over Time | Day 22, pre-dose | 1.13 Beats per minute (bpm) | Standard Deviation 7.45 |
Primary
Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time
Vital sign assessment of RR was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.
Time frame: Baseline (Day 1, pre-dose) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 15 minutes | 0.14 Breaths per minute | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 30 minutes | 0.18 Breaths per minute | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 3 hour | -0.07 Breaths per minute | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 8 hour | 0.02 Breaths per minute | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 5 minutes | -0.05 Breaths per minute | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 30 minutes | 0.07 Breaths per minute | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 27 | -0.14 Breaths per minute | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 5 minutes | 0.07 Breaths per minute | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 1 hour | 0.09 Breaths per minute | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, pre-dose | -0.02 Breaths per minute | Standard Deviation 1.22 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 5 minutes | 0.29 Breaths per minute | Standard Deviation 0.89 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 12 hour | -0.14 Breaths per minute | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 8 hour | -0.33 Breaths per minute | Standard Deviation 1.43 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 2 hour | -0.26 Breaths per minute | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 30 minutes | -0.21 Breaths per minute | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 3 hour | -0.02 Breaths per minute | Standard Deviation 0.94 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 30 minutes | 0.03 Breaths per minute | Standard Deviation 1.04 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, pre-dose | -0.09 Breaths per minute | Standard Deviation 1.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 30 minutes | 0.05 Breaths per minute | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 4 hour | -0.05 Breaths per minute | Standard Deviation 1.09 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 1 hour | 0.16 Breaths per minute | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 1 hour | 0.05 Breaths per minute | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 30 minutes | 0.10 Breaths per minute | Standard Deviation 1.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 35 | -0.35 Breaths per minute | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 1 hour | 0.11 Breaths per minute | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 1 hour | -0.19 Breaths per minute | Standard Deviation 1.3 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 4 hour | -0.05 Breaths per minute | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 24 hour | -0.19 Breaths per minute | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, pre-dose | 0.09 Breaths per minute | Standard Deviation 1.15 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 12 hour | -0.35 Breaths per minute | Standard Deviation 1.34 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 24 hour | -0.16 Breaths per minute | Standard Deviation 1 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 15 minutes | -0.33 Breaths per minute | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 1 hour | 0.13 Breaths per minute | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 5 minutes | -0.02 Breaths per minute | Standard Deviation 1.24 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 2 hour | -0.33 Breaths per minute | Standard Deviation 1.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, pre-dose | 0.00 Breaths per minute | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, pre-dose | 0.02 Breaths per minute | Standard Deviation 1.33 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, pre-dose | 0.09 Breaths per minute | Standard Deviation 1.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, pre-dose | 0.19 Breaths per minute | Standard Deviation 1.05 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 30 minutes | 0.10 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 1 hour | 0.00 Breaths per minute | Standard Deviation 1.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 12 hour | 0.05 Breaths per minute | Standard Deviation 1.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 1 hour | -0.08 Breaths per minute | Standard Deviation 1.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, pre-dose | 0.00 Breaths per minute | Standard Deviation 1 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 2 hour | -0.24 Breaths per minute | Standard Deviation 1.04 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 5 minutes | 0.09 Breaths per minute | Standard Deviation 1 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, pre-dose | -0.05 Breaths per minute | Standard Deviation 1.05 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 30 minutes | 0.05 Breaths per minute | Standard Deviation 1.32 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 30 minutes | -0.08 Breaths per minute | Standard Deviation 1.02 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 15 minutes | -0.08 Breaths per minute | Standard Deviation 1.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, pre-dose | -0.05 Breaths per minute | Standard Deviation 1.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 5 minutes | -0.15 Breaths per minute | Standard Deviation 1.33 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 35 | 0.05 Breaths per minute | Standard Deviation 1.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 15 minutes | -0.07 Breaths per minute | Standard Deviation 1.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 1 hour | 0.00 Breaths per minute | Standard Deviation 1.37 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 8 hour | 0.14 Breaths per minute | Standard Deviation 1 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 30 minutes | 0.05 Breaths per minute | Standard Deviation 1.11 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 1 hour | -0.12 Breaths per minute | Standard Deviation 0.96 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 5 minutes | 0.08 Breaths per minute | Standard Deviation 1.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 12 hour | -0.05 Breaths per minute | Standard Deviation 0.97 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 3 hour | 0.02 Breaths per minute | Standard Deviation 1.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 5 minutes | 0.02 Breaths per minute | Standard Deviation 0.94 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 4 hour | 0.05 Breaths per minute | Standard Deviation 1.08 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 4 hour | -0.07 Breaths per minute | Standard Deviation 1.01 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 27 | 0.11 Breaths per minute | Standard Deviation 0.97 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 8 hour | -0.02 Breaths per minute | Standard Deviation 0.99 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 30 minutes | -0.14 Breaths per minute | Standard Deviation 1.29 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 1 hour | 0.13 Breaths per minute | Standard Deviation 1.09 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 2 hour | 0.19 Breaths per minute | Standard Deviation 1.14 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 30 minutes | 0.08 Breaths per minute | Standard Deviation 1.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 24 hour | 0.09 Breaths per minute | Standard Deviation 1.25 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 24 hour | -0.03 Breaths per minute | Standard Deviation 0.91 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 3 hour | 0.00 Breaths per minute | Standard Deviation 1.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 1 hour | 0.11 Breaths per minute | Standard Deviation 1.09 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 5 minutes | -0.45 Breaths per minute | Standard Deviation 1.37 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, pre-dose | -0.71 Breaths per minute | Standard Deviation 1.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 30 minutes | -0.28 Breaths per minute | Standard Deviation 1.3 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 1 hour | -0.64 Breaths per minute | Standard Deviation 1.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 12 hour | -0.49 Breaths per minute | Standard Deviation 1.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, pre-dose | -0.51 Breaths per minute | Standard Deviation 1.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 27 | -0.67 Breaths per minute | Standard Deviation 1.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 30 minutes | -0.51 Breaths per minute | Standard Deviation 1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 1 hour | -0.41 Breaths per minute | Standard Deviation 1.04 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 30 minutes | -0.32 Breaths per minute | Standard Deviation 1.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 2 hour | -0.68 Breaths per minute | Standard Deviation 1.21 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 24 hour | -0.64 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 8 hour | -0.54 Breaths per minute | Standard Deviation 0.98 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 4 hour | -0.46 Breaths per minute | Standard Deviation 1.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 15 minutes | -0.16 Breaths per minute | Standard Deviation 1.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 30 minutes | 0.19 Breaths per minute | Standard Deviation 0.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 1 hour | -0.23 Breaths per minute | Standard Deviation 1.09 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 3 hour | -0.42 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 4 hour | -0.12 Breaths per minute | Standard Deviation 1.12 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 35 | -0.56 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 8 hour | -0.26 Breaths per minute | Standard Deviation 1.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 12 hour | -0.16 Breaths per minute | Standard Deviation 0.92 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 3 hour | -0.56 Breaths per minute | Standard Deviation 1.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 24 hour | -0.45 Breaths per minute | Standard Deviation 0.9 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, pre-dose | -0.40 Breaths per minute | Standard Deviation 0.9 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 30 minutes | -0.50 Breaths per minute | Standard Deviation 1.25 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 5 minutes | -0.32 Breaths per minute | Standard Deviation 1.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 30 minutes | -0.21 Breaths per minute | Standard Deviation 0.93 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 1 hour | -0.37 Breaths per minute | Standard Deviation 0.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 1 hour | -0.39 Breaths per minute | Standard Deviation 0.97 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, pre-dose | -0.58 Breaths per minute | Standard Deviation 1.12 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, pre-dose | -0.37 Breaths per minute | Standard Deviation 1.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 5 minutes | -0.43 Breaths per minute | Standard Deviation 1.43 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 2 hour | -0.37 Breaths per minute | Standard Deviation 1.11 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 15 minutes | -0.56 Breaths per minute | Standard Deviation 1.12 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 1 hour | -0.37 Breaths per minute | Standard Deviation 1.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 5 minutes | -0.62 Breaths per minute | Standard Deviation 1.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 30 minutes | 0.96 Breaths per minute | Standard Deviation 1.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 5 minutes | 0.10 Breaths per minute | Standard Deviation 1.01 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, pre-dose | 0.24 Breaths per minute | Standard Deviation 0.99 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, pre-dose | 0.17 Breaths per minute | Standard Deviation 1.09 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, pre-dose | 0.10 Breaths per minute | Standard Deviation 1.26 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 15 minutes | 0.30 Breaths per minute | Standard Deviation 1.36 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 2 hour | 0.30 Breaths per minute | Standard Deviation 1.4 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 15 minutes | 0.33 Breaths per minute | Standard Deviation 0.79 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 1 hour | 0.10 Breaths per minute | Standard Deviation 1.08 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 2 hour | 0.10 Breaths per minute | Standard Deviation 1.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 3 hour | 0.31 Breaths per minute | Standard Deviation 1.09 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 4 hour | -0.02 Breaths per minute | Standard Deviation 1.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 8 hour | 0.19 Breaths per minute | Standard Deviation 1.09 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 12 hour | 0.24 Breaths per minute | Standard Deviation 1.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 24 hour | -0.05 Breaths per minute | Standard Deviation 0.76 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, pre-dose | -0.02 Breaths per minute | Standard Deviation 0.78 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 30 minutes | -0.15 Breaths per minute | Standard Deviation 1.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 1 hour | 0.00 Breaths per minute | Standard Deviation 0.74 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 5 minutes | 0.24 Breaths per minute | Standard Deviation 1.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 30 minutes | 0.35 Breaths per minute | Standard Deviation 1 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 1 hour | 0.08 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 5 minutes | 0.07 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 30 minutes | 0.17 Breaths per minute | Standard Deviation 1.32 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 1 hour | 0.10 Breaths per minute | Standard Deviation 1.07 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, pre-dose | 0.10 Breaths per minute | Standard Deviation 1.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 5 minutes | 0.25 Breaths per minute | Standard Deviation 1.19 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 30 minutes | 0.20 Breaths per minute | Standard Deviation 1.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 1 hour | 0.38 Breaths per minute | Standard Deviation 1.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 27 | 0.00 Breaths per minute | Standard Deviation 1.28 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 30 minutes | 0.10 Breaths per minute | Standard Deviation 1.52 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 1 hour | 0.23 Breaths per minute | Standard Deviation 1.54 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 3 hour | 0.10 Breaths per minute | Standard Deviation 1.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 4 hour | 0.25 Breaths per minute | Standard Deviation 1.53 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 8 hour | 0.23 Breaths per minute | Standard Deviation 1.29 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 12 hour | 0.20 Breaths per minute | Standard Deviation 1.11 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 24 hour | 0.13 Breaths per minute | Standard Deviation 1.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 35 | 0.07 Breaths per minute | Standard Deviation 1.47 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 1 hour | 0.11 Breaths per minute | Standard Deviation 0.98 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 30 minutes | -0.08 Breaths per minute | Standard Deviation 0.97 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 15 minutes | -0.05 Breaths per minute | Standard Deviation 1.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, 5 minutes | -0.08 Breaths per minute | Standard Deviation 1.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 8, pre-dose | -0.21 Breaths per minute | Standard Deviation 0.95 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 1 hour | 0.10 Breaths per minute | Standard Deviation 0.9 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 30 minutes | -0.05 Breaths per minute | Standard Deviation 1.06 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 4 hour | 0.07 Breaths per minute | Standard Deviation 1.11 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, 5 minutes | -0.02 Breaths per minute | Standard Deviation 0.92 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 2 hour | -0.10 Breaths per minute | Standard Deviation 0.97 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 2, pre-dose | 0.00 Breaths per minute | Standard Deviation 0.83 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 24 hour | 0.00 Breaths per minute | Standard Deviation 0.83 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 12 hour | 0.31 Breaths per minute | Standard Deviation 1.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 35 | 0.02 Breaths per minute | Standard Deviation 0.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 8 hour | 0.07 Breaths per minute | Standard Deviation 0.89 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 3 hour | 0.17 Breaths per minute | Standard Deviation 1.26 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 24 hour | -0.18 Breaths per minute | Standard Deviation 1.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 4 hour | 0.05 Breaths per minute | Standard Deviation 1.36 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 1 hour | 0.07 Breaths per minute | Standard Deviation 0.97 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 15 minutes | 0.00 Breaths per minute | Standard Deviation 0.99 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 3 hour | -0.13 Breaths per minute | Standard Deviation 1.08 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 2 hour | 0.21 Breaths per minute | Standard Deviation 1.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 8 hour | -0.08 Breaths per minute | Standard Deviation 1.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 1 hour | -0.05 Breaths per minute | Standard Deviation 1.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 30 minutes | -0.03 Breaths per minute | Standard Deviation 1.04 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 27 | 0.26 Breaths per minute | Standard Deviation 1.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 1, 30 minutes | -0.02 Breaths per minute | Standard Deviation 1.14 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, 12 hour | 0.03 Breaths per minute | Standard Deviation 1.25 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 1 hour | 0.00 Breaths per minute | Standard Deviation 1.25 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 5 minutes | 0.13 Breaths per minute | Standard Deviation 1 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, pre-dose | 0.13 Breaths per minute | Standard Deviation 1.03 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 22, 30 minutes | 0.03 Breaths per minute | Standard Deviation 1.07 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 1 hour | -0.11 Breaths per minute | Standard Deviation 1.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 30 minutes | 0.03 Breaths per minute | Standard Deviation 1.03 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, 5 minutes | -0.08 Breaths per minute | Standard Deviation 1.12 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 28, pre-dose | 0.03 Breaths per minute | Standard Deviation 0.78 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Respiratory Rate (RR) Over Time | Day 15, pre-dose | 0.00 Breaths per minute | Standard Deviation 0.99 |
Primary
Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time
Vital sign assessment of SBP and DBP was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.
Time frame: Baseline (Day 1, pre-dose) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, pre-dose | -1.21 Millimeter of mercury (mmHg) | Standard Deviation 6.9 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 5 minutes | -2.81 Millimeter of mercury (mmHg) | Standard Deviation 9.74 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 15 minutes | -1.49 Millimeter of mercury (mmHg) | Standard Deviation 9.45 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 30 minutes | -2.51 Millimeter of mercury (mmHg) | Standard Deviation 7.91 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 35 | -2.07 Millimeter of mercury (mmHg) | Standard Deviation 9.11 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 1 hour | -2.89 Millimeter of mercury (mmHg) | Standard Deviation 6.88 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 24 hour | -3.40 Millimeter of mercury (mmHg) | Standard Deviation 8.66 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 27 | -2.86 Millimeter of mercury (mmHg) | Standard Deviation 7.04 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 12 hour | -3.58 Millimeter of mercury (mmHg) | Standard Deviation 6.27 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, pre-dose | -3.67 Millimeter of mercury (mmHg) | Standard Deviation 6.62 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 8 hour | -3.02 Millimeter of mercury (mmHg) | Standard Deviation 7.16 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 15 minutes | -4.37 Millimeter of mercury (mmHg) | Standard Deviation 7.42 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 5 minutes | -3.67 Millimeter of mercury (mmHg) | Standard Deviation 10.94 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 4 hour | -3.30 Millimeter of mercury (mmHg) | Standard Deviation 7.23 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 2 hour | -4.14 Millimeter of mercury (mmHg) | Standard Deviation 8.05 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 1 hour | -2.70 Millimeter of mercury (mmHg) | Standard Deviation 6.65 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 3 hour | -2.33 Millimeter of mercury (mmHg) | Standard Deviation 10.78 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 30 minutes | -1.37 Millimeter of mercury (mmHg) | Standard Deviation 5.98 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 2 hour | -5.07 Millimeter of mercury (mmHg) | Standard Deviation 12.33 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 1 hour | -4.74 Millimeter of mercury (mmHg) | Standard Deviation 11.62 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 3 hour | -4.33 Millimeter of mercury (mmHg) | Standard Deviation 11.33 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 5 minutes | -3.05 Millimeter of mercury (mmHg) | Standard Deviation 8.91 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 30 minutes | -4.07 Millimeter of mercury (mmHg) | Standard Deviation 11.26 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 4 hour | -4.28 Millimeter of mercury (mmHg) | Standard Deviation 11.36 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 15 minutes | -4.58 Millimeter of mercury (mmHg) | Standard Deviation 11.88 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 8 hour | -4.51 Millimeter of mercury (mmHg) | Standard Deviation 12.32 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, pre-dose | -2.60 Millimeter of mercury (mmHg) | Standard Deviation 10.39 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 12 hour | -4.95 Millimeter of mercury (mmHg) | Standard Deviation 11.61 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 27 | -2.91 Millimeter of mercury (mmHg) | Standard Deviation 9.87 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 24 hour | -4.05 Millimeter of mercury (mmHg) | Standard Deviation 11.72 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 8 hour | -4.07 Millimeter of mercury (mmHg) | Standard Deviation 9.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 1 hour | -3.39 Millimeter of mercury (mmHg) | Standard Deviation 9.31 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 35 | -4.44 Millimeter of mercury (mmHg) | Standard Deviation 12.39 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 2 hour | -1.60 Millimeter of mercury (mmHg) | Standard Deviation 10.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 4 hour | -3.51 Millimeter of mercury (mmHg) | Standard Deviation 11.38 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 30 minutes | -3.03 Millimeter of mercury (mmHg) | Standard Deviation 10.05 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 15 minutes | -1.12 Millimeter of mercury (mmHg) | Standard Deviation 6.71 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 30 minutes | -2.36 Millimeter of mercury (mmHg) | Standard Deviation 7.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 5 minutes | -3.77 Millimeter of mercury (mmHg) | Standard Deviation 11.97 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 1 hour | -1.65 Millimeter of mercury (mmHg) | Standard Deviation 7.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 12 hour | -3.02 Millimeter of mercury (mmHg) | Standard Deviation 12.64 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, pre-dose | -2.07 Millimeter of mercury (mmHg) | Standard Deviation 9.75 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 2 hour | -0.74 Millimeter of mercury (mmHg) | Standard Deviation 7.5 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 3 hour | -1.74 Millimeter of mercury (mmHg) | Standard Deviation 6.08 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 1 hour | -3.50 Millimeter of mercury (mmHg) | Standard Deviation 10.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 4 hour | -1.86 Millimeter of mercury (mmHg) | Standard Deviation 7.88 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 30 minutes | -3.56 Millimeter of mercury (mmHg) | Standard Deviation 10.28 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 8 hour | -2.16 Millimeter of mercury (mmHg) | Standard Deviation 6.91 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 5 minutes | -4.16 Millimeter of mercury (mmHg) | Standard Deviation 12.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 3 hour | -3.31 Millimeter of mercury (mmHg) | Standard Deviation 7.58 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 5 minutes | -1.62 Millimeter of mercury (mmHg) | Standard Deviation 7.05 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 1 hour | -3.58 Millimeter of mercury (mmHg) | Standard Deviation 7.11 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, pre-dose | -1.24 Millimeter of mercury (mmHg) | Standard Deviation 6.23 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 24 hour | -1.41 Millimeter of mercury (mmHg) | Standard Deviation 6.11 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 30 minutes | -4.37 Millimeter of mercury (mmHg) | Standard Deviation 7.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 30 minutes | -1.71 Millimeter of mercury (mmHg) | Standard Deviation 6.37 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, pre-dose | -2.77 Millimeter of mercury (mmHg) | Standard Deviation 10.88 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 1 hour | -2.24 Millimeter of mercury (mmHg) | Standard Deviation 10.22 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, pre-dose | -1.50 Millimeter of mercury (mmHg) | Standard Deviation 8.09 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 30 minutes | -1.72 Millimeter of mercury (mmHg) | Standard Deviation 9.1 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 5 minutes | -2.45 Millimeter of mercury (mmHg) | Standard Deviation 9.16 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 24 hour | -1.14 Millimeter of mercury (mmHg) | Standard Deviation 6.07 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, pre-dose | -2.83 Millimeter of mercury (mmHg) | Standard Deviation 10.96 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 1 hour | -2.03 Millimeter of mercury (mmHg) | Standard Deviation 7.15 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, pre-dose | -1.64 Millimeter of mercury (mmHg) | Standard Deviation 8.49 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 1 hour | -3.22 Millimeter of mercury (mmHg) | Standard Deviation 8.67 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 1 hour | -2.51 Millimeter of mercury (mmHg) | Standard Deviation 10.03 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, pre-dose | -2.30 Millimeter of mercury (mmHg) | Standard Deviation 8.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 30 minutes | -3.13 Millimeter of mercury (mmHg) | Standard Deviation 8.79 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 5 minutes | -2.70 Millimeter of mercury (mmHg) | Standard Deviation 8.54 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 30 minutes | -3.33 Millimeter of mercury (mmHg) | Standard Deviation 7.98 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 1 hour | -3.26 Millimeter of mercury (mmHg) | Standard Deviation 5.95 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 12 hour | -1.40 Millimeter of mercury (mmHg) | Standard Deviation 8.76 |
| Placebo | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 30 minutes | -1.44 Millimeter of mercury (mmHg) | Standard Deviation 7.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 5 minutes | -1.46 Millimeter of mercury (mmHg) | Standard Deviation 6.87 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, pre-dose | -1.90 Millimeter of mercury (mmHg) | Standard Deviation 6.53 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 30 minutes | -0.45 Millimeter of mercury (mmHg) | Standard Deviation 6.74 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 15 minutes | 1.30 Millimeter of mercury (mmHg) | Standard Deviation 8.36 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 5 minutes | -1.62 Millimeter of mercury (mmHg) | Standard Deviation 6.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 24 hour | -0.14 Millimeter of mercury (mmHg) | Standard Deviation 6.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 35 | -0.69 Millimeter of mercury (mmHg) | Standard Deviation 6.38 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 24 hour | 0.14 Millimeter of mercury (mmHg) | Standard Deviation 4.75 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 5 minutes | -0.47 Millimeter of mercury (mmHg) | Standard Deviation 7.07 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 30 minutes | -1.05 Millimeter of mercury (mmHg) | Standard Deviation 4.35 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 24 hour | -0.71 Millimeter of mercury (mmHg) | Standard Deviation 7.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 1 hour | -0.18 Millimeter of mercury (mmHg) | Standard Deviation 6.95 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 1 hour | -1.36 Millimeter of mercury (mmHg) | Standard Deviation 6.41 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, pre-dose | -0.67 Millimeter of mercury (mmHg) | Standard Deviation 8.49 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 12 hour | -1.82 Millimeter of mercury (mmHg) | Standard Deviation 6.56 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 1 hour | -1.09 Millimeter of mercury (mmHg) | Standard Deviation 5.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 30 minutes | -0.43 Millimeter of mercury (mmHg) | Standard Deviation 6.81 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 1 hour | -1.00 Millimeter of mercury (mmHg) | Standard Deviation 5.68 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 8 hour | -1.03 Millimeter of mercury (mmHg) | Standard Deviation 5.91 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 30 minutes | 0.02 Millimeter of mercury (mmHg) | Standard Deviation 6.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, pre-dose | 0.14 Millimeter of mercury (mmHg) | Standard Deviation 5.71 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 8 hour | -0.56 Millimeter of mercury (mmHg) | Standard Deviation 6.42 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 30 minutes | -0.05 Millimeter of mercury (mmHg) | Standard Deviation 7.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 2 hour | -1.26 Millimeter of mercury (mmHg) | Standard Deviation 6.08 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 15 minutes | -1.24 Millimeter of mercury (mmHg) | Standard Deviation 9.26 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 12 hour | 0.02 Millimeter of mercury (mmHg) | Standard Deviation 7.63 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 4 hour | -1.57 Millimeter of mercury (mmHg) | Standard Deviation 5.51 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 1 hour | -0.24 Millimeter of mercury (mmHg) | Standard Deviation 6.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 30 minutes | -0.81 Millimeter of mercury (mmHg) | Standard Deviation 7.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 3 hour | -2.70 Millimeter of mercury (mmHg) | Standard Deviation 7.08 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, pre-dose | -1.30 Millimeter of mercury (mmHg) | Standard Deviation 6.65 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 2 hour | -2.41 Millimeter of mercury (mmHg) | Standard Deviation 5.89 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 5 minutes | -1.47 Millimeter of mercury (mmHg) | Standard Deviation 5.5 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 3 hour | -1.28 Millimeter of mercury (mmHg) | Standard Deviation 6.03 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 2 hour | -0.51 Millimeter of mercury (mmHg) | Standard Deviation 5.51 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 3 hour | -1.14 Millimeter of mercury (mmHg) | Standard Deviation 5.58 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 30 minutes | -0.85 Millimeter of mercury (mmHg) | Standard Deviation 6.48 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 2 hour | -2.65 Millimeter of mercury (mmHg) | Standard Deviation 6.63 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 15 minutes | -0.42 Millimeter of mercury (mmHg) | Standard Deviation 5.13 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, pre-dose | -0.10 Millimeter of mercury (mmHg) | Standard Deviation 7.49 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 27 | -1.00 Millimeter of mercury (mmHg) | Standard Deviation 7.53 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 1 hour | -2.78 Millimeter of mercury (mmHg) | Standard Deviation 6.77 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 4 hour | -0.77 Millimeter of mercury (mmHg) | Standard Deviation 6.56 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 5 minutes | -0.81 Millimeter of mercury (mmHg) | Standard Deviation 5.67 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 3 hour | -2.84 Millimeter of mercury (mmHg) | Standard Deviation 6.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 30 minutes | -0.61 Millimeter of mercury (mmHg) | Standard Deviation 8.31 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 30 minutes | -2.65 Millimeter of mercury (mmHg) | Standard Deviation 6.47 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 8 hour | -0.93 Millimeter of mercury (mmHg) | Standard Deviation 7.06 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 5 minutes | -1.65 Millimeter of mercury (mmHg) | Standard Deviation 6.94 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 4 hour | -3.16 Millimeter of mercury (mmHg) | Standard Deviation 6.86 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 4 hour | -1.53 Millimeter of mercury (mmHg) | Standard Deviation 6.52 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 15 minutes | -1.86 Millimeter of mercury (mmHg) | Standard Deviation 7.11 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 5 minutes | -1.15 Millimeter of mercury (mmHg) | Standard Deviation 6.47 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, pre-dose | -1.63 Millimeter of mercury (mmHg) | Standard Deviation 6.22 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 8 hour | -2.11 Millimeter of mercury (mmHg) | Standard Deviation 7.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 30 minutes | -2.53 Millimeter of mercury (mmHg) | Standard Deviation 6.6 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, pre-dose | -0.05 Millimeter of mercury (mmHg) | Standard Deviation 7.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 30 minutes | -1.93 Millimeter of mercury (mmHg) | Standard Deviation 6.43 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, pre-dose | -0.30 Millimeter of mercury (mmHg) | Standard Deviation 6.49 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 12 hour | -0.97 Millimeter of mercury (mmHg) | Standard Deviation 6.73 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 1 hour | 0.92 Millimeter of mercury (mmHg) | Standard Deviation 7.57 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 27 | -0.49 Millimeter of mercury (mmHg) | Standard Deviation 7.74 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 1 hour | -2.00 Millimeter of mercury (mmHg) | Standard Deviation 6.94 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 1 hour | -0.81 Millimeter of mercury (mmHg) | Standard Deviation 6.78 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 24 hour | -1.42 Millimeter of mercury (mmHg) | Standard Deviation 6.82 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 1 hour | -0.48 Millimeter of mercury (mmHg) | Standard Deviation 6.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 1 hour | -1.64 Millimeter of mercury (mmHg) | Standard Deviation 6.68 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, pre-dose | -0.28 Millimeter of mercury (mmHg) | Standard Deviation 6.08 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 5 minutes | -0.60 Millimeter of mercury (mmHg) | Standard Deviation 8.26 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 35 | -2.83 Millimeter of mercury (mmHg) | Standard Deviation 7.47 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 1 hour | -0.93 Millimeter of mercury (mmHg) | Standard Deviation 6.54 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 30 minutes | -1.56 Millimeter of mercury (mmHg) | Standard Deviation 6.64 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, pre-dose | -0.43 Millimeter of mercury (mmHg) | Standard Deviation 7.22 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 12 hour | -0.16 Millimeter of mercury (mmHg) | Standard Deviation 7.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 30 minutes | -1.47 Millimeter of mercury (mmHg) | Standard Deviation 5.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 3 hour | -1.98 Millimeter of mercury (mmHg) | Standard Deviation 7.22 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 4 hour | -0.86 Millimeter of mercury (mmHg) | Standard Deviation 7.33 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 8 hour | 0.39 Millimeter of mercury (mmHg) | Standard Deviation 6.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 12 hour | 0.02 Millimeter of mercury (mmHg) | Standard Deviation 7.78 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 30 minutes | -1.77 Millimeter of mercury (mmHg) | Standard Deviation 6.69 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 1 hour | -1.51 Millimeter of mercury (mmHg) | Standard Deviation 8.29 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 2 hour | -0.98 Millimeter of mercury (mmHg) | Standard Deviation 9.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 3 hour | -2.60 Millimeter of mercury (mmHg) | Standard Deviation 8.32 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 4 hour | -2.21 Millimeter of mercury (mmHg) | Standard Deviation 7.89 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 8 hour | -1.45 Millimeter of mercury (mmHg) | Standard Deviation 8.96 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 12 hour | -2.14 Millimeter of mercury (mmHg) | Standard Deviation 8.08 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 24 hour | -1.45 Millimeter of mercury (mmHg) | Standard Deviation 7.42 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 35 | -0.70 Millimeter of mercury (mmHg) | Standard Deviation 8.05 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 15 minutes | -1.41 Millimeter of mercury (mmHg) | Standard Deviation 6.44 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 30 minutes | -1.73 Millimeter of mercury (mmHg) | Standard Deviation 5.87 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 1 hour | -1.89 Millimeter of mercury (mmHg) | Standard Deviation 5.91 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 2 hour | -1.66 Millimeter of mercury (mmHg) | Standard Deviation 5.69 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 3 hour | -2.57 Millimeter of mercury (mmHg) | Standard Deviation 5.6 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 4 hour | -2.00 Millimeter of mercury (mmHg) | Standard Deviation 6.46 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 24 hour | -1.14 Millimeter of mercury (mmHg) | Standard Deviation 6.91 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 5 minutes | -0.68 Millimeter of mercury (mmHg) | Standard Deviation 6.46 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 30 minutes | -1.79 Millimeter of mercury (mmHg) | Standard Deviation 6.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 30 minutes | -1.71 Millimeter of mercury (mmHg) | Standard Deviation 7.1 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 1 hour | -1.61 Millimeter of mercury (mmHg) | Standard Deviation 7.42 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 5 minutes | -0.98 Millimeter of mercury (mmHg) | Standard Deviation 8.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 1 hour | -2.23 Millimeter of mercury (mmHg) | Standard Deviation 7.04 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, pre-dose | -0.67 Millimeter of mercury (mmHg) | Standard Deviation 6.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 30 minutes | -1.51 Millimeter of mercury (mmHg) | Standard Deviation 7.44 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 27 | -1.43 Millimeter of mercury (mmHg) | Standard Deviation 6.32 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, pre-dose | -1.31 Millimeter of mercury (mmHg) | Standard Deviation 6.66 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 15 minutes | -1.19 Millimeter of mercury (mmHg) | Standard Deviation 5.58 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 3 hour | -2.71 Millimeter of mercury (mmHg) | Standard Deviation 5.26 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 4 hour | -2.64 Millimeter of mercury (mmHg) | Standard Deviation 5.92 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 8 hour | -1.57 Millimeter of mercury (mmHg) | Standard Deviation 6.91 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 12 hour | -1.93 Millimeter of mercury (mmHg) | Standard Deviation 5.85 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 24 hour | -2.38 Millimeter of mercury (mmHg) | Standard Deviation 5.41 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 15 minutes | 0.36 Millimeter of mercury (mmHg) | Standard Deviation 5.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 30 minutes | 1.36 Millimeter of mercury (mmHg) | Standard Deviation 5.59 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 1 hour | -0.02 Millimeter of mercury (mmHg) | Standard Deviation 6.33 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 2 hour | -1.45 Millimeter of mercury (mmHg) | Standard Deviation 7.3 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 24 hour | -0.44 Millimeter of mercury (mmHg) | Standard Deviation 5.68 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, pre-dose | -1.05 Millimeter of mercury (mmHg) | Standard Deviation 6.85 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 5 minutes | -0.54 Millimeter of mercury (mmHg) | Standard Deviation 5.78 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 1 hour | -1.34 Millimeter of mercury (mmHg) | Standard Deviation 7.33 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, pre-dose | 0.42 Millimeter of mercury (mmHg) | Standard Deviation 10.22 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 5 minutes | 1.00 Millimeter of mercury (mmHg) | Standard Deviation 7.76 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 30 minutes | -0.29 Millimeter of mercury (mmHg) | Standard Deviation 7.82 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 1 hour | -1.71 Millimeter of mercury (mmHg) | Standard Deviation 7.8 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, pre-dose | 0.65 Millimeter of mercury (mmHg) | Standard Deviation 8.22 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 30 minutes | -1.57 Millimeter of mercury (mmHg) | Standard Deviation 6.01 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 1 hour | -1.07 Millimeter of mercury (mmHg) | Standard Deviation 7.63 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 2 hour | -0.93 Millimeter of mercury (mmHg) | Standard Deviation 6.69 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 35 | -2.33 Millimeter of mercury (mmHg) | Standard Deviation 8.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 5 minutes | 0.69 Millimeter of mercury (mmHg) | Standard Deviation 8.67 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 30 minutes | 0.03 Millimeter of mercury (mmHg) | Standard Deviation 8.98 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 1 hour | -0.54 Millimeter of mercury (mmHg) | Standard Deviation 7.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, pre-dose | -0.53 Millimeter of mercury (mmHg) | Standard Deviation 8.71 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 5 minutes | -0.57 Millimeter of mercury (mmHg) | Standard Deviation 6.72 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 27 | -0.48 Millimeter of mercury (mmHg) | Standard Deviation 8.68 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, pre-dose | -1.10 Millimeter of mercury (mmHg) | Standard Deviation 9.35 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 15 minutes | -1.21 Millimeter of mercury (mmHg) | Standard Deviation 9.99 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 30 minutes | -1.69 Millimeter of mercury (mmHg) | Standard Deviation 9.7 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 1 hour | -1.26 Millimeter of mercury (mmHg) | Standard Deviation 8.4 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 8 hour | -0.73 Millimeter of mercury (mmHg) | Standard Deviation 6.23 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 12 hour | -1.64 Millimeter of mercury (mmHg) | Standard Deviation 7.81 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, pre-dose | -1.02 Millimeter of mercury (mmHg) | Standard Deviation 6.93 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 1 hour | -1.68 Millimeter of mercury (mmHg) | Standard Deviation 6.87 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, pre-dose | -0.88 Millimeter of mercury (mmHg) | Standard Deviation 7.49 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 5 minutes | -0.98 Millimeter of mercury (mmHg) | Standard Deviation 7.06 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, pre-dose | -1.21 Millimeter of mercury (mmHg) | Standard Deviation 6.46 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 30 minutes | -2.15 Millimeter of mercury (mmHg) | Standard Deviation 7.73 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 5 minutes | -1.67 Millimeter of mercury (mmHg) | Standard Deviation 8.62 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 1 hour | -1.31 Millimeter of mercury (mmHg) | Standard Deviation 7.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 15 minutes | -0.63 Millimeter of mercury (mmHg) | Standard Deviation 8.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 3 hour | -1.81 Millimeter of mercury (mmHg) | Standard Deviation 6.73 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 1 hour | -1.32 Millimeter of mercury (mmHg) | Standard Deviation 7.67 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 5 minutes | -0.40 Millimeter of mercury (mmHg) | Standard Deviation 6.67 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, pre-dose | -0.90 Millimeter of mercury (mmHg) | Standard Deviation 6.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 30 minutes | -2.00 Millimeter of mercury (mmHg) | Standard Deviation 6.88 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 1 hour | -1.63 Millimeter of mercury (mmHg) | Standard Deviation 6.95 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 5 minutes | -1.85 Millimeter of mercury (mmHg) | Standard Deviation 6.57 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 30 minutes | -0.70 Millimeter of mercury (mmHg) | Standard Deviation 5.89 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, pre-dose | 0.68 Millimeter of mercury (mmHg) | Standard Deviation 9.93 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 5 minutes | 1.20 Millimeter of mercury (mmHg) | Standard Deviation 9.63 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, pre-dose | 0.02 Millimeter of mercury (mmHg) | Standard Deviation 6.8 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, pre-dose | -0.31 Millimeter of mercury (mmHg) | Standard Deviation 6.79 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 30 minutes | 0.33 Millimeter of mercury (mmHg) | Standard Deviation 9.31 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 1 hour | -1.10 Millimeter of mercury (mmHg) | Standard Deviation 6.84 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 1 hour | -2.75 Millimeter of mercury (mmHg) | Standard Deviation 10.3 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 5 minutes | -0.88 Millimeter of mercury (mmHg) | Standard Deviation 7.27 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 24 hour | -0.02 Millimeter of mercury (mmHg) | Standard Deviation 5.26 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 30 minutes | -1.05 Millimeter of mercury (mmHg) | Standard Deviation 8.9 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 24 hour | -0.76 Millimeter of mercury (mmHg) | Standard Deviation 6.84 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 4 hour | -3.71 Millimeter of mercury (mmHg) | Standard Deviation 8.71 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, pre-dose | -0.90 Millimeter of mercury (mmHg) | Standard Deviation 7.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 3 hour | -2.15 Millimeter of mercury (mmHg) | Standard Deviation 7.83 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 35 | 0.61 Millimeter of mercury (mmHg) | Standard Deviation 7.29 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 12 hour | -1.24 Millimeter of mercury (mmHg) | Standard Deviation 6.14 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 8 hour | -1.98 Millimeter of mercury (mmHg) | Standard Deviation 6.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 5 minutes | -0.27 Millimeter of mercury (mmHg) | Standard Deviation 7.89 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 4 hour | -0.90 Millimeter of mercury (mmHg) | Standard Deviation 6.81 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 12 hour | -0.83 Millimeter of mercury (mmHg) | Standard Deviation 8.3 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 30 minutes | -1.83 Millimeter of mercury (mmHg) | Standard Deviation 9.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 2 hour | -0.45 Millimeter of mercury (mmHg) | Standard Deviation 5.32 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 30 minutes | -1.80 Millimeter of mercury (mmHg) | Standard Deviation 6.99 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 1 hour | -0.98 Millimeter of mercury (mmHg) | Standard Deviation 9.96 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 1 hour | -0.95 Millimeter of mercury (mmHg) | Standard Deviation 5.64 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 30 minutes | -0.29 Millimeter of mercury (mmHg) | Standard Deviation 5.75 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, pre-dose | -0.08 Millimeter of mercury (mmHg) | Standard Deviation 9.92 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 15 minutes | -0.38 Millimeter of mercury (mmHg) | Standard Deviation 5.96 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, pre-dose | 0.63 Millimeter of mercury (mmHg) | Standard Deviation 8.86 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 5 minutes | 0.08 Millimeter of mercury (mmHg) | Standard Deviation 9.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 30 minutes | -1.10 Millimeter of mercury (mmHg) | Standard Deviation 9.78 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 24 hour | -0.08 Millimeter of mercury (mmHg) | Standard Deviation 8.02 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 1 hour | -0.85 Millimeter of mercury (mmHg) | Standard Deviation 9.57 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 12 hour | -0.75 Millimeter of mercury (mmHg) | Standard Deviation 8.48 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 3 hour | -1.33 Millimeter of mercury (mmHg) | Standard Deviation 6.61 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 27 | 0.15 Millimeter of mercury (mmHg) | Standard Deviation 9.04 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 8 hour | -2.83 Millimeter of mercury (mmHg) | Standard Deviation 9.35 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 1 hour | -1.83 Millimeter of mercury (mmHg) | Standard Deviation 5.68 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 4 hour | -3.48 Millimeter of mercury (mmHg) | Standard Deviation 9.35 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 5 minutes | -0.24 Millimeter of mercury (mmHg) | Standard Deviation 5.72 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 15 minutes | -0.63 Millimeter of mercury (mmHg) | Standard Deviation 9.6 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 3 hour | -2.03 Millimeter of mercury (mmHg) | Standard Deviation 8.98 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 8 hour | -2.26 Millimeter of mercury (mmHg) | Standard Deviation 8.5 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 30 minutes | -1.43 Millimeter of mercury (mmHg) | Standard Deviation 9.09 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 2 hour | -2.90 Millimeter of mercury (mmHg) | Standard Deviation 7.32 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 2 hour | -2.13 Millimeter of mercury (mmHg) | Standard Deviation 7.57 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 1 hour | -1.45 Millimeter of mercury (mmHg) | Standard Deviation 7.37 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 30 minutes | -2.39 Millimeter of mercury (mmHg) | Standard Deviation 8.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 1 hour | -2.13 Millimeter of mercury (mmHg) | Standard Deviation 9.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 4 hour | -2.10 Millimeter of mercury (mmHg) | Standard Deviation 7.73 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, pre-dose | 0.25 Millimeter of mercury (mmHg) | Standard Deviation 8.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 35 | 0.37 Millimeter of mercury (mmHg) | Standard Deviation 8.66 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 8 hour | -1.10 Millimeter of mercury (mmHg) | Standard Deviation 7.73 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 27 | -0.75 Millimeter of mercury (mmHg) | Standard Deviation 6.53 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 12 hour | -0.90 Millimeter of mercury (mmHg) | Standard Deviation 8.45 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 1 hour | -1.35 Millimeter of mercury (mmHg) | Standard Deviation 8.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 24 hour | -1.35 Millimeter of mercury (mmHg) | Standard Deviation 8.34 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 30 minutes | -0.98 Millimeter of mercury (mmHg) | Standard Deviation 8.78 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, pre-dose | 0.76 Millimeter of mercury (mmHg) | Standard Deviation 9.66 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 5 minutes | -0.90 Millimeter of mercury (mmHg) | Standard Deviation 8.44 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, pre-dose | 0.70 Millimeter of mercury (mmHg) | Standard Deviation 9.92 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 15 minutes | -0.88 Millimeter of mercury (mmHg) | Standard Deviation 5.13 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 1 hour | -2.07 Millimeter of mercury (mmHg) | Standard Deviation 7.31 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 30 minutes | -0.95 Millimeter of mercury (mmHg) | Standard Deviation 6.05 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 2 hour | -1.64 Millimeter of mercury (mmHg) | Standard Deviation 7.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 5 minutes | -2.54 Millimeter of mercury (mmHg) | Standard Deviation 7.7 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 5 minutes | -1.33 Millimeter of mercury (mmHg) | Standard Deviation 7.03 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 2 hour | -3.55 Millimeter of mercury (mmHg) | Standard Deviation 6.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, pre-dose | -0.63 Millimeter of mercury (mmHg) | Standard Deviation 6.74 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 2 hour | -2.93 Millimeter of mercury (mmHg) | Standard Deviation 7.77 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 5 minutes | -1.18 Millimeter of mercury (mmHg) | Standard Deviation 9.91 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 4 hour | -2.74 Millimeter of mercury (mmHg) | Standard Deviation 8.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 5 minutes | -1.45 Millimeter of mercury (mmHg) | Standard Deviation 8 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 3 hour | -2.71 Millimeter of mercury (mmHg) | Standard Deviation 7.61 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 1 hour | -2.16 Millimeter of mercury (mmHg) | Standard Deviation 5.54 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, pre-dose | 0.03 Millimeter of mercury (mmHg) | Standard Deviation 8.5 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 30 minutes | -1.38 Millimeter of mercury (mmHg) | Standard Deviation 6.88 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 30 minutes | -2.05 Millimeter of mercury (mmHg) | Standard Deviation 8.73 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 30 minutes | -2.58 Millimeter of mercury (mmHg) | Standard Deviation 4.68 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 24 hour | -3.00 Millimeter of mercury (mmHg) | Standard Deviation 8.28 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, 1 hour | -0.88 Millimeter of mercury (mmHg) | Standard Deviation 7.38 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 30 minutes | -1.10 Millimeter of mercury (mmHg) | Standard Deviation 6.8 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, 5 minutes | -2.38 Millimeter of mercury (mmHg) | Standard Deviation 4.86 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 8 hour | -1.52 Millimeter of mercury (mmHg) | Standard Deviation 6.69 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 27 | -2.69 Millimeter of mercury (mmHg) | Standard Deviation 6.22 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, pre-dose | -1.36 Millimeter of mercury (mmHg) | Standard Deviation 8.57 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 2, pre-dose | -2.50 Millimeter of mercury (mmHg) | Standard Deviation 7.7 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, 1 hour | -2.24 Millimeter of mercury (mmHg) | Standard Deviation 9.37 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 5 minutes | -0.73 Millimeter of mercury (mmHg) | Standard Deviation 7.93 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 8, pre-dose | -2.05 Millimeter of mercury (mmHg) | Standard Deviation 6.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 12 hour | -0.82 Millimeter of mercury (mmHg) | Standard Deviation 9.52 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, pre-dose | -0.44 Millimeter of mercury (mmHg) | Standard Deviation 8.08 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 30 minutes | -2.37 Millimeter of mercury (mmHg) | Standard Deviation 6.26 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 1 hour | -1.80 Millimeter of mercury (mmHg) | Standard Deviation 6.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 8 hour | -1.33 Millimeter of mercury (mmHg) | Standard Deviation 6.32 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, pre-dose | -1.28 Millimeter of mercury (mmHg) | Standard Deviation 6.3 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 27 | -1.05 Millimeter of mercury (mmHg) | Standard Deviation 8.69 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 1 hour | -1.87 Millimeter of mercury (mmHg) | Standard Deviation 7.66 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 30 minutes | -2.45 Millimeter of mercury (mmHg) | Standard Deviation 5.6 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, 5 minutes | -2.62 Millimeter of mercury (mmHg) | Standard Deviation 5.79 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 24 hour | -1.39 Millimeter of mercury (mmHg) | Standard Deviation 6.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 8 hour | -1.85 Millimeter of mercury (mmHg) | Standard Deviation 9.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 8, 30 minutes | -1.92 Millimeter of mercury (mmHg) | Standard Deviation 8.31 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 1 hour | -2.89 Millimeter of mercury (mmHg) | Standard Deviation 6.67 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 30 minutes | -2.41 Millimeter of mercury (mmHg) | Standard Deviation 6.83 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 24 hour | -2.38 Millimeter of mercury (mmHg) | Standard Deviation 6.05 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, pre-dose | -0.90 Millimeter of mercury (mmHg) | Standard Deviation 8.04 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 4 hour | -2.21 Millimeter of mercury (mmHg) | Standard Deviation 7.56 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 1 hour | -3.62 Millimeter of mercury (mmHg) | Standard Deviation 5.98 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 1 hour | -3.85 Millimeter of mercury (mmHg) | Standard Deviation 7.35 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 12 hour | -0.38 Millimeter of mercury (mmHg) | Standard Deviation 5.78 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 15 minutes | -0.24 Millimeter of mercury (mmHg) | Standard Deviation 5.45 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 3 hour | -1.90 Millimeter of mercury (mmHg) | Standard Deviation 6.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 4 hour | -2.23 Millimeter of mercury (mmHg) | Standard Deviation 5.44 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 2, pre-dose | -2.33 Millimeter of mercury (mmHg) | Standard Deviation 6.43 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 12 hour | -0.97 Millimeter of mercury (mmHg) | Standard Deviation 6.97 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 35 | -1.46 Millimeter of mercury (mmHg) | Standard Deviation 7.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 15 minutes | -1.56 Millimeter of mercury (mmHg) | Standard Deviation 8.34 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 3 hour | -1.79 Millimeter of mercury (mmHg) | Standard Deviation 9.01 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 12 hour | 0.81 Millimeter of mercury (mmHg) | Standard Deviation 8.03 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 15, 1 hour | -2.24 Millimeter of mercury (mmHg) | Standard Deviation 5.51 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 5 minutes | -1.18 Millimeter of mercury (mmHg) | Standard Deviation 8.75 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 4 hour | -1.69 Millimeter of mercury (mmHg) | Standard Deviation 5.05 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 22, 30 minutes | -1.30 Millimeter of mercury (mmHg) | Standard Deviation 6.45 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 15 minutes | -1.55 Millimeter of mercury (mmHg) | Standard Deviation 5.67 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 30 minutes | -2.44 Millimeter of mercury (mmHg) | Standard Deviation 8.02 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 30 minutes | -1.97 Millimeter of mercury (mmHg) | Standard Deviation 8.36 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 3 hour | -1.76 Millimeter of mercury (mmHg) | Standard Deviation 5.13 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 28, 2 hour | -3.21 Millimeter of mercury (mmHg) | Standard Deviation 8.7 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 1 hour | -2.83 Millimeter of mercury (mmHg) | Standard Deviation 5.33 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 24 hour | -2.21 Millimeter of mercury (mmHg) | Standard Deviation 6.83 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 15, 1 hour | -1.50 Millimeter of mercury (mmHg) | Standard Deviation 7.91 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 2 hour | -2.62 Millimeter of mercury (mmHg) | Standard Deviation 5.42 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 1, 30 minutes | -1.88 Millimeter of mercury (mmHg) | Standard Deviation 5.87 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 8 hour | -1.45 Millimeter of mercury (mmHg) | Standard Deviation 7.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 1, 1 hour | -1.40 Millimeter of mercury (mmHg) | Standard Deviation 7.11 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 22, pre-dose | 0.08 Millimeter of mercury (mmHg) | Standard Deviation 10.59 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | DBP, Day 28, 15 minutes | -1.28 Millimeter of mercury (mmHg) | Standard Deviation 6.84 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Time | SBP, Day 35 | -0.51 Millimeter of mercury (mmHg) | Standard Deviation 9.88 |
Primary
Change From Baseline in Vital Sign Parameter of Temperature Over Time
Vital sign assessment of temperature was done at Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose), Day 2 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 8 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 15 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 22 (pre-dose, 5 minutes, 30 minutes and 1 hour post-dose), Day 27, Day 28 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours and 24 hours post-dose) and Day 35. A window of plus or minus 5 minutes was allowed during the active treatment visit vital sign assessments. Baseline was defined as the assessment done on Day 1 (pre-dose). The change from Baseline was calculated by subtracting the Baseline value (Day 1, pre-dose) from the individual post-Baseline (Day 1, Day 2, Day 8, Day 15, Day 22, Day 27, Day 28 and Day 35) values.
Time frame: Baseline (Day 1, pre-dose) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 4 hour | -0.01 Degree celcius | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 1 hour | 0.05 Degree celcius | Standard Deviation 0.18 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, pre-dose | 0.00 Degree celcius | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 30 minutes | 0.04 Degree celcius | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 15 minutes | 0.03 Degree celcius | Standard Deviation 0.12 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 12 hour | 0.05 Degree celcius | Standard Deviation 0.16 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 1 hour | 0.02 Degree celcius | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, pre-dose | -0.00 Degree celcius | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 27 | 0.04 Degree celcius | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 2 hour | 0.02 Degree celcius | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 3 hour | 0.02 Degree celcius | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 2 hour | 0.03 Degree celcius | Standard Deviation 0.19 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 30 minutes | 0.02 Degree celcius | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 15 minutes | 0.02 Degree celcius | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 1 hour | 0.02 Degree celcius | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 5 minutes | 0.02 Degree celcius | Standard Deviation 0.18 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 35 | -0.00 Degree celcius | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 30 minutes | 0.04 Degree celcius | Standard Deviation 0.16 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 5 minutes | 0.01 Degree celcius | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 30 minutes | 0.05 Degree celcius | Standard Deviation 0.13 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 1 hour | 0.05 Degree celcius | Standard Deviation 0.14 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 30 minutes | 0.07 Degree celcius | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, pre-dose | 0.07 Degree celcius | Standard Deviation 0.25 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, pre-dose | 0.03 Degree celcius | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 30 minutes | 0.06 Degree celcius | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 24 hour | -0.01 Degree celcius | Standard Deviation 0.22 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 5 minutes | 0.05 Degree celcius | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 8 hour | 0.05 Degree celcius | Standard Deviation 0.21 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 1 hour | 0.04 Degree celcius | Standard Deviation 0.11 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 1 hour | 0.03 Degree celcius | Standard Deviation 0.14 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, pre-dose | 0.02 Degree celcius | Standard Deviation 0.15 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 24 hour | 0.03 Degree celcius | Standard Deviation 0.16 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 12 hour | 0.12 Degree celcius | Standard Deviation 0.24 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 5 minutes | 0.05 Degree celcius | Standard Deviation 0.2 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 8 hour | 0.07 Degree celcius | Standard Deviation 0.23 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 4 hour | 0.05 Degree celcius | Standard Deviation 0.17 |
| Placebo | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 3 hour | 0.05 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, pre-dose | 0.03 Degree celcius | Standard Deviation 0.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 1 hour | -0.00 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 3 hour | -0.00 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 4 hour | 0.02 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 8 hour | 0.03 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 5 minutes | -0.00 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 5 minutes | 0.03 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 30 minutes | 0.00 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 1 hour | 0.04 Degree celcius | Standard Deviation 0.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 30 minutes | -0.01 Degree celcius | Standard Deviation 0.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 1 hour | -0.04 Degree celcius | Standard Deviation 0.28 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 8 hour | 0.05 Degree celcius | Standard Deviation 0.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 35 | 0.07 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 15 minutes | -0.00 Degree celcius | Standard Deviation 0.14 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 30 minutes | -0.01 Degree celcius | Standard Deviation 0.12 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 2 hour | 0.01 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 12 hour | 0.01 Degree celcius | Standard Deviation 0.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 24 hour | -0.03 Degree celcius | Standard Deviation 0.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, pre-dose | -0.03 Degree celcius | Standard Deviation 0.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 30 minutes | -0.00 Degree celcius | Standard Deviation 0.15 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 1 hour | -0.00 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 1 hour | 0.01 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, pre-dose | 0.00 Degree celcius | Standard Deviation 0.17 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 5 minutes | 0.01 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 30 minutes | -0.01 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, pre-dose | 0.04 Degree celcius | Standard Deviation 0.25 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 5 minutes | 0.04 Degree celcius | Standard Deviation 0.23 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 30 minutes | 0.04 Degree celcius | Standard Deviation 0.21 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 1 hour | 0.05 Degree celcius | Standard Deviation 0.21 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 27 | 0.01 Degree celcius | Standard Deviation 0.24 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, pre-dose | -0.00 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 15 minutes | -0.00 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 2 hour | -0.00 Degree celcius | Standard Deviation 0.25 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 3 hour | 0.01 Degree celcius | Standard Deviation 0.26 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 4 hour | 0.00 Degree celcius | Standard Deviation 0.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 12 hour | 0.06 Degree celcius | Standard Deviation 0.27 |
| SRT2104 0.25 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 24 hour | -0.02 Degree celcius | Standard Deviation 0.25 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, pre-dose | 0.02 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, pre-dose | 0.00 Degree celcius | Standard Deviation 0.24 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 12 hour | 0.03 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, pre-dose | -0.01 Degree celcius | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 24 hour | -0.09 Degree celcius | Standard Deviation 0.35 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 1 hour | -0.02 Degree celcius | Standard Deviation 0.21 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 27 | 0.01 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 3 hour | -0.03 Degree celcius | Standard Deviation 0.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 4 hour | 0.02 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, pre-dose | 0.02 Degree celcius | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 8 hour | 0.00 Degree celcius | Standard Deviation 0.17 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 5 minutes | 0.01 Degree celcius | Standard Deviation 0.2 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 1 hour | 0.01 Degree celcius | Standard Deviation 0.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 5 minutes | -0.00 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 2 hour | -0.04 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 2 hour | 0.02 Degree celcius | Standard Deviation 0.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 30 minutes | -0.01 Degree celcius | Standard Deviation 0.14 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 1 hour | -0.02 Degree celcius | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, pre-dose | -0.02 Degree celcius | Standard Deviation 0.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 30 minutes | -0.03 Degree celcius | Standard Deviation 0.12 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 24 hour | 0.01 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 30 minutes | -0.01 Degree celcius | Standard Deviation 0.17 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 3 hour | -0.01 Degree celcius | Standard Deviation 0.21 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 35 | -0.02 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 30 minutes | -0.01 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 5 minutes | 0.01 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 4 hour | -0.02 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 1 hour | 0.00 Degree celcius | Standard Deviation 0.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 15 minutes | 0.00 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 30 minutes | -0.03 Degree celcius | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 30 minutes | -0.00 Degree celcius | Standard Deviation 0.13 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 1 hour | -0.00 Degree celcius | Standard Deviation 0.16 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 15 minutes | 0.01 Degree celcius | Standard Deviation 0.11 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 12 hour | 0.01 Degree celcius | Standard Deviation 0.18 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 1 hour | -0.01 Degree celcius | Standard Deviation 0.15 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 5 minutes | 0.01 Degree celcius | Standard Deviation 0.19 |
| SRT2104 0.5 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 8 hour | 0.03 Degree celcius | Standard Deviation 0.14 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 1 hour | 0.04 Degree celcius | Standard Deviation 0.1 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 3 hour | 0.02 Degree celcius | Standard Deviation 0.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 2 hour | 0.06 Degree celcius | Standard Deviation 0.15 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 3 hour | 0.06 Degree celcius | Standard Deviation 0.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 4 hour | 0.05 Degree celcius | Standard Deviation 0.15 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 5 minutes | 0.05 Degree celcius | Standard Deviation 0.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 12 hour | 0.05 Degree celcius | Standard Deviation 0.15 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, pre-dose | 0.06 Degree celcius | Standard Deviation 0.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 1 hour | 0.03 Degree celcius | Standard Deviation 0.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, pre-dose | 0.01 Degree celcius | Standard Deviation 0.19 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 30 minutes | 0.02 Degree celcius | Standard Deviation 0.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 4 hour | 0.02 Degree celcius | Standard Deviation 0.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 1 hour | 0.03 Degree celcius | Standard Deviation 0.14 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, pre-dose | 0.02 Degree celcius | Standard Deviation 0.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 5 minutes | 0.01 Degree celcius | Standard Deviation 0.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 30 minutes | 0.03 Degree celcius | Standard Deviation 0.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 15 minutes | 0.04 Degree celcius | Standard Deviation 0.13 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 8 hour | 0.05 Degree celcius | Standard Deviation 0.17 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 30 minutes | 0.05 Degree celcius | Standard Deviation 0.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 35 | 0.07 Degree celcius | Standard Deviation 0.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, pre-dose | -0.01 Degree celcius | Standard Deviation 0.25 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 12 hour | 0.05 Degree celcius | Standard Deviation 0.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 5 minutes | -0.03 Degree celcius | Standard Deviation 0.16 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 30 minutes | 0.03 Degree celcius | Standard Deviation 0.23 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 27 | 0.05 Degree celcius | Standard Deviation 0.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 24 hour | 0.02 Degree celcius | Standard Deviation 0.26 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 24 hour | 0.01 Degree celcius | Standard Deviation 0.19 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 1 hour | 0.04 Degree celcius | Standard Deviation 0.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 8 hour | 0.05 Degree celcius | Standard Deviation 0.14 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 1 hour | 0.02 Degree celcius | Standard Deviation 0.22 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, pre-dose | 0.00 Degree celcius | Standard Deviation 0.19 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 15 minutes | 0.04 Degree celcius | Standard Deviation 0.21 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 30 minutes | 0.05 Degree celcius | Standard Deviation 0.24 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 2 hour | 0.04 Degree celcius | Standard Deviation 0.18 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 5 minutes | -0.01 Degree celcius | Standard Deviation 0.2 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 30 minutes | 0.04 Degree celcius | Standard Deviation 0.12 |
| SRT2104 1.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 1 hour | 0.04 Degree celcius | Standard Deviation 0.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, pre-dose | -0.01 Degree celcius | Standard Deviation 0.18 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 5 minutes | 0.03 Degree celcius | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, pre-dose | 0.01 Degree celcius | Standard Deviation 0.19 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 2 hour | 0.02 Degree celcius | Standard Deviation 0.13 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 2 hour | 0.05 Degree celcius | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 30 minutes | 0.02 Degree celcius | Standard Deviation 0.17 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, pre-dose | -0.01 Degree celcius | Standard Deviation 0.22 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 1 hour | 0.00 Degree celcius | Standard Deviation 0.12 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 30 minutes | 0.03 Degree celcius | Standard Deviation 0.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 1 hour | 0.01 Degree celcius | Standard Deviation 0.09 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 27 | 0.03 Degree celcius | Standard Deviation 0.13 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 8 hour | 0.02 Degree celcius | Standard Deviation 0.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 15 minutes | 0.01 Degree celcius | Standard Deviation 0.26 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 30 minutes | 0.06 Degree celcius | Standard Deviation 0.22 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, pre-dose | 0.01 Degree celcius | Standard Deviation 0.1 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 15 minutes | -0.00 Degree celcius | Standard Deviation 0.17 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 24 hour | -0.02 Degree celcius | Standard Deviation 0.19 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 24 hour | 0.00 Degree celcius | Standard Deviation 0.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 3 hour | 0.01 Degree celcius | Standard Deviation 0.2 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 4 hour | 0.03 Degree celcius | Standard Deviation 0.26 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 1 hour | 0.01 Degree celcius | Standard Deviation 0.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 12 hour | 0.06 Degree celcius | Standard Deviation 0.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 5 minutes | 0.05 Degree celcius | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 30 minutes | 0.03 Degree celcius | Standard Deviation 0.21 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, 1 hour | 0.04 Degree celcius | Standard Deviation 0.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 3 hour | 0.00 Degree celcius | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 12 hour | -0.01 Degree celcius | Standard Deviation 0.15 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 8 hour | 0.02 Degree celcius | Standard Deviation 0.16 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 30 minutes | 0.01 Degree celcius | Standard Deviation 0.1 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 2, pre-dose | 0.01 Degree celcius | Standard Deviation 0.23 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 1, 1 hour | 0.03 Degree celcius | Standard Deviation 0.26 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 15, 5 minutes | 0.02 Degree celcius | Standard Deviation 0.24 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 35 | 0.02 Degree celcius | Standard Deviation 0.32 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 1 hour | 0.03 Degree celcius | Standard Deviation 0.24 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 22, 5 minutes | 0.00 Degree celcius | Standard Deviation 0.12 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 28, 4 hour | 0.01 Degree celcius | Standard Deviation 0.11 |
| SRT2104 2.0 g/Day | Change From Baseline in Vital Sign Parameter of Temperature Over Time | Day 8, 30 minutes | 0.04 Degree celcius | Standard Deviation 0.2 |
Primary
Mean Change From Baseline in Weight Over Time
Participant's body weight was assessed in the beginning of the study (at Day 1) and at the end of the study (Day 28 and Day 35). The clinical staff was instructed to use calibrated scales for weight measurement. The same scale was used at the clinical site for all participants at each specified time point during the study. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: Safety Analysis Set Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in Weight Over Time | Day 28 | -0.17 Kilogram (kg) | Standard Deviation 1.25 |
| Placebo | Mean Change From Baseline in Weight Over Time | Day 35 | -0.40 Kilogram (kg) | Standard Deviation 1.39 |
| SRT2104 0.25 g/Day | Mean Change From Baseline in Weight Over Time | Day 35 | -0.91 Kilogram (kg) | Standard Deviation 2.9 |
| SRT2104 0.25 g/Day | Mean Change From Baseline in Weight Over Time | Day 28 | -0.81 Kilogram (kg) | Standard Deviation 2.21 |
| SRT2104 0.5 g/Day | Mean Change From Baseline in Weight Over Time | Day 28 | -1.25 Kilogram (kg) | Standard Deviation 2.06 |
| SRT2104 0.5 g/Day | Mean Change From Baseline in Weight Over Time | Day 35 | -1.32 Kilogram (kg) | Standard Deviation 1.89 |
| SRT2104 1.0 g/Day | Mean Change From Baseline in Weight Over Time | Day 28 | -0.56 Kilogram (kg) | Standard Deviation 1.68 |
| SRT2104 1.0 g/Day | Mean Change From Baseline in Weight Over Time | Day 35 | -0.86 Kilogram (kg) | Standard Deviation 1.78 |
| SRT2104 2.0 g/Day | Mean Change From Baseline in Weight Over Time | Day 35 | -2.74 Kilogram (kg) | Standard Deviation 7.27 |
| SRT2104 2.0 g/Day | Mean Change From Baseline in Weight Over Time | Day 28 | -1.54 Kilogram (kg) | Standard Deviation 3.82 |
Primary
Number of Participants With AE by Intensity of Mild, Moderate and Severe
Intensity for each AE was categorized as mild, moderate and severe. Mild was defined as awareness of sign or symptom, but easily tolerated; moderate was defined as discomfort enough to cause interference with normal daily activities; severe was defined as inability to perform normal daily activities.
Time frame: Up to Follow-up (58 days)
Population: Safety Analysis Set Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Mild AE | 8 Participants |
| Placebo | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Severe AE | 0 Participants |
| Placebo | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Moderate AE | 7 Participants |
| SRT2104 0.25 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Moderate AE | 6 Participants |
| SRT2104 0.25 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Mild AE | 10 Participants |
| SRT2104 0.25 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Severe AE | 1 Participants |
| SRT2104 0.5 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Moderate AE | 12 Participants |
| SRT2104 0.5 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Mild AE | 11 Participants |
| SRT2104 0.5 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Severe AE | 1 Participants |
| SRT2104 1.0 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Mild AE | 8 Participants |
| SRT2104 1.0 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Severe AE | 0 Participants |
| SRT2104 1.0 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Moderate AE | 5 Participants |
| SRT2104 2.0 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Moderate AE | 7 Participants |
| SRT2104 2.0 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Mild AE | 9 Participants |
| SRT2104 2.0 g/Day | Number of Participants With AE by Intensity of Mild, Moderate and Severe | Severe AE | 0 Participants |
Primary
Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. AE's were classified as related to the study medication, based on the investigator's judgment.
Time frame: Up to Follow-up (58 days)
Population: Safety Analysis Set (SAF) Population was defined as all participants who received at least one dose of any test material during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE related to study medication | 0 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE | 11 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any fatal AE of death | 0 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any SAE | 0 Participants |
| Placebo | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE leading to discontinuation | 0 Participants |
| SRT2104 0.25 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE leading to discontinuation | 3 Participants |
| SRT2104 0.25 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE related to study medication | 1 Participants |
| SRT2104 0.25 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any fatal AE of death | 0 Participants |
| SRT2104 0.25 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE | 15 Participants |
| SRT2104 0.25 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any SAE | 1 Participants |
| SRT2104 0.5 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE | 19 Participants |
| SRT2104 0.5 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any SAE | 1 Participants |
| SRT2104 0.5 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE related to study medication | 0 Participants |
| SRT2104 0.5 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE leading to discontinuation | 2 Participants |
| SRT2104 0.5 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any fatal AE of death | 1 Participants |
| SRT2104 1.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE | 11 Participants |
| SRT2104 1.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any SAE | 0 Participants |
| SRT2104 1.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE leading to discontinuation | 1 Participants |
| SRT2104 1.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE related to study medication | 1 Participants |
| SRT2104 1.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any fatal AE of death | 0 Participants |
| SRT2104 2.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE related to study medication | 1 Participants |
| SRT2104 2.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE | 15 Participants |
| SRT2104 2.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any AE leading to discontinuation | 2 Participants |
| SRT2104 2.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any fatal AE of death | 0 Participants |
| SRT2104 2.0 g/Day | Number of Participants With Any Adverse Event (AE), Serious Adverse Event (SAE), AE Related to Study Medication, AE Leading to Discontinuation and Fatal AE of Death | Any SAE | 0 Participants |
Comparison: Placebo versus SRT2104 0.25 g/day in number of participants with any AE.p-value: 0.4816Fisher Exact
Comparison: Placebo versus SRT2104 0.5 g/day in number of participants with any AE.p-value: 0.1147Fisher Exact
Comparison: Placebo versus SRT2104 1.0 g/day in number of participants with any AE.p-value: 1Fisher Exact
Comparison: Placebo versus SRT2104 2.0 g/day in number of participants with any AE.p-value: 0.4816Fisher Exact
Primary
Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28
Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. On Day 1, Day 2 and Day 29, participants fasted for at least 10 hour overnight. The post-dose sample was collected within 2 minutes of the scheduled time. The first occurrence of the Cmax was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 28 | 185.418 ng/mL | Standard Deviation 162.5 |
| Placebo | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 1 | 178.729 ng/mL | Standard Deviation 179.982 |
| SRT2104 0.25 g/Day | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 1 | 366.694 ng/mL | Standard Deviation 322.951 |
| SRT2104 0.25 g/Day | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 28 | 329.973 ng/mL | Standard Deviation 266.174 |
| SRT2104 0.5 g/Day | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 1 | 336.562 ng/mL | Standard Deviation 298.042 |
| SRT2104 0.5 g/Day | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 28 | 375.395 ng/mL | Standard Deviation 333.188 |
| SRT2104 1.0 g/Day | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 28 | 433.650 ng/mL | Standard Deviation 461.441 |
| SRT2104 1.0 g/Day | Observed Maximum Plasma Concentration (Cmax) of SRT2104 at Day 1 and Day 28 | Day 1 | 417.832 ng/mL | Standard Deviation 470.048 |
Comparison: Day 28 versus Day 1 for Cmax of SRT2104 0.25 g/day.90% CI: [86.94, 171.8]ANOVA
Comparison: Day 28 versus Day 1 for Cmax of SRT2104 0.5 g/day.90% CI: [69.07, 129.16]ANOVA
Comparison: Day 28 versus Day 1 for Cmax of SRT2104 1.0 g/day.90% CI: [91.54, 143.95]ANOVA
Comparison: Day 28 versus Day 1 for Cmax of SRT2104 2.0 g/day.90% CI: [88.66, 163.23]ANOVA
Primary
Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28
Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. On Day 1 Day 2 and Day 29, participants fasted for at least 10 hour overnight. The t1/2 was obtained as the ratio of ln2/λz, where λz is the terminal phase rate constant estimated by linear regression analysis of the concentration-time data.
Time frame: Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 1 | 13.4184 hour |
| Placebo | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 28 | 18.0115 hour |
| SRT2104 0.25 g/Day | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 1 | 12.1669 hour |
| SRT2104 0.25 g/Day | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 28 | 20.3500 hour |
| SRT2104 0.5 g/Day | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 28 | 18.9258 hour |
| SRT2104 0.5 g/Day | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 1 | 13.3434 hour |
| SRT2104 1.0 g/Day | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 28 | 17.4548 hour |
| SRT2104 1.0 g/Day | Terminal Elimination Half Life (T1/2) of SRT2104 at Day 1 and Day 28 | Day 1 | 9.7846 hour |
Primary
Time to Cmax (Tmax) at Day 1 and Day 28
Blood samples were collected on Day 1 (pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8 (pre-dose), Day 15 (pre-dose), Day 22 (pre-dose), Day 28 (pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hour, 3 hour, 4 hour, 8 hour and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose). The pre-dose sample was collected within one hour prior to study medication administration. The post-dose sample was collected within 2 minutes of the scheduled time. The time at which Cmax was observed was determined directly from the raw concentration-time data.
Time frame: Day 1 (pre-dose, 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose), Day 2 (24 hour post-Day 1 dose), Day 8, 15 and 22 (pre-dose), Day 28 (pre-dose, and 15 and 30 minutes, 1, 2, 3, 4, 8 and 12 hour post-dose) and Day 29 (24 hour post-Day 28 dose)
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 1 | 3.000 hour |
| Placebo | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 28 | 3.000 hour |
| SRT2104 0.25 g/Day | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 28 | 3.000 hour |
| SRT2104 0.25 g/Day | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 1 | 3.000 hour |
| SRT2104 0.5 g/Day | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 1 | 3.000 hour |
| SRT2104 0.5 g/Day | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 28 | 3.000 hour |
| SRT2104 1.0 g/Day | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 1 | 4.000 hour |
| SRT2104 1.0 g/Day | Time to Cmax (Tmax) at Day 1 and Day 28 | Day 28 | 3.000 hour |
Secondary
AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28
The assessment of PPG and PPI was performed at 30 minutes, 60 minnutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. AUC with respect to these time interval was calculated using the linear trapezoidal rule by the sum of the areas between each chronological pair of assessments (using observed times) for PPG and PPI.
Time frame: Day 1 (30 minutes, 60 minutes and 2 hour) and Day 28 (30 minutes, 60 minutes and 2 hour)
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPI | 423.8 mmol*hour per liter | Standard Deviation 289.68 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPG | 25.89 mmol*hour per liter | Standard Deviation 5.84 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPG | 12.35 mmol*hour per liter | Standard Deviation 2.45 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPG | 13.10 mmol*hour per liter | Standard Deviation 2.69 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPI | 212.1 mmol*hour per liter | Standard Deviation 176.25 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPI | 192.4 mmol*hour per liter | Standard Deviation 121.08 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPI | 444.8 mmol*hour per liter | Standard Deviation 332.82 |
| Placebo | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPG | 27.39 mmol*hour per liter | Standard Deviation 5.72 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPI | 207.1 mmol*hour per liter | Standard Deviation 202.43 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPI | 478.8 mmol*hour per liter | Standard Deviation 584.46 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPG | 14.08 mmol*hour per liter | Standard Deviation 3.4 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPG | 29.35 mmol*hour per liter | Standard Deviation 7.64 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPG | 25.98 mmol*hour per liter | Standard Deviation 5.64 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPG | 12.52 mmol*hour per liter | Standard Deviation 2.41 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPI | 211.1 mmol*hour per liter | Standard Deviation 245.53 |
| SRT2104 0.25 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPI | 477.7 mmol*hour per liter | Standard Deviation 538.49 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPI | 394.5 mmol*hour per liter | Standard Deviation 276.65 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPI | 418.4 mmol*hour per liter | Standard Deviation 251.25 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPG | 14.28 mmol*hour per liter | Standard Deviation 3.5 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPI | 176.6 mmol*hour per liter | Standard Deviation 105.51 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPG | 29.87 mmol*hour per liter | Standard Deviation 7.2 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPG | 13.25 mmol*hour per liter | Standard Deviation 2.58 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPG | 28.30 mmol*hour per liter | Standard Deviation 5.51 |
| SRT2104 0.5 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPI | 168.1 mmol*hour per liter | Standard Deviation 135.71 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPI | 168.3 mmol*hour per liter | Standard Deviation 123.33 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPG | 12.92 mmol*hour per liter | Standard Deviation 2.27 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPG | 29.95 mmol*hour per liter | Standard Deviation 9.34 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPG | 27.01 mmol*hour per liter | Standard Deviation 5.11 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPG | 14.43 mmol*hour per liter | Standard Deviation 4.18 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPI | 138.8 mmol*hour per liter | Standard Deviation 120.34 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPI | 377.6 mmol*hour per liter | Standard Deviation 297.27 |
| SRT2104 1.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPI | 334.7 mmol*hour per liter | Standard Deviation 256.51 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPI | 164.6 mmol*hour per liter | Standard Deviation 175.64 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPI | 186.0 mmol*hour per liter | Standard Deviation 92.55 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPG | 24.14 mmol*hour per liter | Standard Deviation 6.4 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-1, PPG | 12.68 mmol*hour per liter | Standard Deviation 2.73 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-2, PPI | 381.3 mmol*hour per liter | Standard Deviation 378.7 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPG | 26.07 mmol*hour per liter | Standard Deviation 5.99 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 28, AUC 0-1, PPG | 11.33 mmol*hour per liter | Standard Deviation 2.63 |
| SRT2104 2.0 g/Day | AUC From Time 0 to 1 h (AUC 0-1) and AUC From Time 0 to 2 h (AUC 0-2) for PPG and PPI at Day 1 and Day 28 | Day 1, AUC 0-2, PPI | 385.8 mmol*hour per liter | Standard Deviation 167.81 |
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPG.p-value: 0.9788Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPG.p-value: 0.1214Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPG.p-value: 0.206Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPG.p-value: 0.179Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPG.p-value: 0.2741Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPG.p-value: 0.6001Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPG.p-value: 0.6711Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPG.p-value: 0.1361Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPG.p-value: 0.3369Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 28 for PPG.p-value: 0.0975Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPG.p-value: 0.2184Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPG.p-value: 0.1013Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPG.p-value: 0.3286Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPG.p-value: 0.5193Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPG.p-value: 0.5751Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPG.p-value: 0.2409Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 1 for PPI.p-value: 0.4829Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 1 for PPI.p-value: 0.7563Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 1 for PPI.p-value: 0.2907Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-1 at Day 1 for PPI.p-value: 0.7663Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPIp-value: 0.5825Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-1 at Day 28 for PPI.p-value: 0.322Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-1 at Day 28 for PPI.p-value: 0.0564Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-1 at Day 28 for PPI.p-value: 0.196Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 1 for PPI.p-value: 0.5997Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 1 for PPI.p-value: 0.9637Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 1 for PPI.p-value: 0.324Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 1 for PPI.p-value: 0.844Wilcoxon test
Comparison: Placebo versus SRT2104 0.25 g/day of AUC 0-2 at Day 28 for PPI.p-value: 0.6483Wilcoxon test
Comparison: Placebo versus SRT2104 0.5 g/day of AUC 0-2 at Day 28 for PPI.p-value: 0.6452Wilcoxon test
Comparison: Placebo versus SRT2104 1.0 g/day of AUC 0-2 at Day 28 for PPI.p-value: 0.1253Wilcoxon test
Comparison: Placebo versus SRT2104 2.0 g/day of AUC 0-2 at Day 28 for PPI.p-value: 0.2583Wilcoxon test
Secondary
Change From Baseline in FPG Levels Over Time
The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in FPG Levels Over Time | Day 28 | -1.17 mmol per liter | Standard Deviation 2.42 |
| Placebo | Change From Baseline in FPG Levels Over Time | Day 15 | -0.72 mmol per liter | Standard Deviation 2.45 |
| Placebo | Change From Baseline in FPG Levels Over Time | Day 35 | -0.73 mmol per liter | Standard Deviation 2.7 |
| Placebo | Change From Baseline in FPG Levels Over Time | Day 22 | -0.74 mmol per liter | Standard Deviation 2.48 |
| Placebo | Change From Baseline in FPG Levels Over Time | Day 8 | -0.30 mmol per liter | Standard Deviation 2.2 |
| SRT2104 0.25 g/Day | Change From Baseline in FPG Levels Over Time | Day 22 | -1.06 mmol per liter | Standard Deviation 3.63 |
| SRT2104 0.25 g/Day | Change From Baseline in FPG Levels Over Time | Day 15 | -0.91 mmol per liter | Standard Deviation 2.61 |
| SRT2104 0.25 g/Day | Change From Baseline in FPG Levels Over Time | Day 28 | -1.11 mmol per liter | Standard Deviation 3.45 |
| SRT2104 0.25 g/Day | Change From Baseline in FPG Levels Over Time | Day 35 | -0.94 mmol per liter | Standard Deviation 2.47 |
| SRT2104 0.25 g/Day | Change From Baseline in FPG Levels Over Time | Day 8 | -1.00 mmol per liter | Standard Deviation 3.23 |
| SRT2104 0.5 g/Day | Change From Baseline in FPG Levels Over Time | Day 15 | -0.41 mmol per liter | Standard Deviation 2.35 |
| SRT2104 0.5 g/Day | Change From Baseline in FPG Levels Over Time | Day 28 | -0.52 mmol per liter | Standard Deviation 2.6 |
| SRT2104 0.5 g/Day | Change From Baseline in FPG Levels Over Time | Day 22 | 0.28 mmol per liter | Standard Deviation 2.79 |
| SRT2104 0.5 g/Day | Change From Baseline in FPG Levels Over Time | Day 35 | -1.24 mmol per liter | Standard Deviation 3.07 |
| SRT2104 0.5 g/Day | Change From Baseline in FPG Levels Over Time | Day 8 | 0.16 mmol per liter | Standard Deviation 2.06 |
| SRT2104 1.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 35 | -1.52 mmol per liter | Standard Deviation 3.29 |
| SRT2104 1.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 8 | -0.41 mmol per liter | Standard Deviation 2.77 |
| SRT2104 1.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 15 | -0.64 mmol per liter | Standard Deviation 2.78 |
| SRT2104 1.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 28 | -0.97 mmol per liter | Standard Deviation 2.83 |
| SRT2104 1.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 22 | -0.47 mmol per liter | Standard Deviation 2.9 |
| SRT2104 2.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 28 | -0.15 mmol per liter | Standard Deviation 2.38 |
| SRT2104 2.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 35 | -1.14 mmol per liter | Standard Deviation 2.37 |
| SRT2104 2.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 22 | 0.40 mmol per liter | Standard Deviation 2.71 |
| SRT2104 2.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 15 | 0.17 mmol per liter | Standard Deviation 2.72 |
| SRT2104 2.0 g/Day | Change From Baseline in FPG Levels Over Time | Day 8 | 0.17 mmol per liter | Standard Deviation 2.05 |
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 8.p-value: 0.525ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 8.p-value: 0.818ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 8.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 8.p-value: 0.809ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 15.p-value: 0.993ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 15.p-value: 0.954ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 15.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 15.p-value: 0.344ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 22.p-value: 0.968ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 22.p-value: 0.316ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 22.p-value: 0.984ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 22.p-value: 0.235ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 28.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 28.p-value: 0.656ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 28.p-value: 0.994ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 28.p-value: 0.285ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPG on Day 35.p-value: 0.992ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPG on Day 35.p-value: 0.822ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPG on Day 35.p-value: 0.538ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPG on Day 35.p-value: 0.907ANOVA
Secondary
Change From Baseline in FPI Over Time
The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. Baseline was defined as the assessment done on Day 1. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 8, Day 15, Day 22, Day 28 and Day 35) values.
Time frame: Baseline (Day 1) and up to Day 35
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in FPI Over Time | Day 28 | 1.0 mmol per liter | Standard Deviation 51.66 |
| Placebo | Change From Baseline in FPI Over Time | Day 8 | 7.2 mmol per liter | Standard Deviation 66.75 |
| Placebo | Change From Baseline in FPI Over Time | Day 35 | 20.4 mmol per liter | Standard Deviation 80.92 |
| Placebo | Change From Baseline in FPI Over Time | Day 15 | 10.8 mmol per liter | Standard Deviation 77.13 |
| Placebo | Change From Baseline in FPI Over Time | Day 22 | 17.6 mmol per liter | Standard Deviation 90.89 |
| SRT2104 0.25 g/Day | Change From Baseline in FPI Over Time | Day 28 | 8.9 mmol per liter | Standard Deviation 95.04 |
| SRT2104 0.25 g/Day | Change From Baseline in FPI Over Time | Day 22 | -4.6 mmol per liter | Standard Deviation 55.62 |
| SRT2104 0.25 g/Day | Change From Baseline in FPI Over Time | Day 15 | -6.5 mmol per liter | Standard Deviation 48.51 |
| SRT2104 0.25 g/Day | Change From Baseline in FPI Over Time | Day 35 | 30.7 mmol per liter | Standard Deviation 103.55 |
| SRT2104 0.25 g/Day | Change From Baseline in FPI Over Time | Day 8 | 12.2 mmol per liter | Standard Deviation 80.2 |
| SRT2104 0.5 g/Day | Change From Baseline in FPI Over Time | Day 22 | 10.6 mmol per liter | Standard Deviation 56.34 |
| SRT2104 0.5 g/Day | Change From Baseline in FPI Over Time | Day 8 | 12.3 mmol per liter | Standard Deviation 49.91 |
| SRT2104 0.5 g/Day | Change From Baseline in FPI Over Time | Day 15 | 8.1 mmol per liter | Standard Deviation 45.43 |
| SRT2104 0.5 g/Day | Change From Baseline in FPI Over Time | Day 28 | -6.9 mmol per liter | Standard Deviation 41.45 |
| SRT2104 0.5 g/Day | Change From Baseline in FPI Over Time | Day 35 | 13.7 mmol per liter | Standard Deviation 47.92 |
| SRT2104 1.0 g/Day | Change From Baseline in FPI Over Time | Day 35 | 22.3 mmol per liter | Standard Deviation 79.42 |
| SRT2104 1.0 g/Day | Change From Baseline in FPI Over Time | Day 8 | 12.9 mmol per liter | Standard Deviation 63.97 |
| SRT2104 1.0 g/Day | Change From Baseline in FPI Over Time | Day 28 | 4.1 mmol per liter | Standard Deviation 57.16 |
| SRT2104 1.0 g/Day | Change From Baseline in FPI Over Time | Day 22 | 20.2 mmol per liter | Standard Deviation 75.69 |
| SRT2104 1.0 g/Day | Change From Baseline in FPI Over Time | Day 15 | 18.8 mmol per liter | Standard Deviation 88.06 |
| SRT2104 2.0 g/Day | Change From Baseline in FPI Over Time | Day 22 | 0.3 mmol per liter | Standard Deviation 49.95 |
| SRT2104 2.0 g/Day | Change From Baseline in FPI Over Time | Day 28 | 15.2 mmol per liter | Standard Deviation 138.79 |
| SRT2104 2.0 g/Day | Change From Baseline in FPI Over Time | Day 8 | 4.7 mmol per liter | Standard Deviation 37.72 |
| SRT2104 2.0 g/Day | Change From Baseline in FPI Over Time | Day 35 | 48.0 mmol per liter | Standard Deviation 216.64 |
| SRT2104 2.0 g/Day | Change From Baseline in FPI Over Time | Day 15 | 8.3 mmol per liter | Standard Deviation 96.6 |
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 8.p-value: 0.989ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 8.p-value: 0.989ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 8.p-value: 0.982ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 8.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 15.p-value: 0.685ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 15.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 15.p-value: 0.971ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 15.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 22.p-value: 0.405ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 22.p-value: 0.975ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 22.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 22.p-value: 0.629ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 28.p-value: 0.982ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 28.p-value: 0.982ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 28.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 28.p-value: 0.874ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in FPI on Day 35.p-value: 0.986ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in FPI on Day 35.p-value: 0.997ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in FPI on Day 35.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in FPI on Day 35.p-value: 0.697ANOVA
Secondary
Change From Baseline in Fructosamine Levels at Day 28
Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.
Time frame: Baseline (Day 1) and Day 28
Population: ITT Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Fructosamine Levels at Day 28 | -14.37 mmol per liter | Standard Deviation 41.18 |
| SRT2104 0.25 g/Day | Change From Baseline in Fructosamine Levels at Day 28 | -6.67 mmol per liter | Standard Deviation 40.27 |
| SRT2104 0.5 g/Day | Change From Baseline in Fructosamine Levels at Day 28 | 9.76 mmol per liter | Standard Deviation 62.77 |
| SRT2104 1.0 g/Day | Change From Baseline in Fructosamine Levels at Day 28 | -4.68 mmol per liter | Standard Deviation 44.64 |
| SRT2104 2.0 g/Day | Change From Baseline in Fructosamine Levels at Day 28 | -2.14 mmol per liter | Standard Deviation 48.83 |
p-value: 0.896ANOVA
p-value: 0.08ANOVA
p-value: 0.792ANOVA
p-value: 0.645ANOVA
Secondary
Change From Baseline in HbA1c Levels at Day 28
HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months. The sample for HbA1c assessment was collected on Day 1 and Day 28. Baseline value was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.
Time frame: Baseline (Day 1) and Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HbA1c Levels at Day 28 | -0.31 Percentage of HbA1c | Standard Deviation 0.55 |
| SRT2104 0.25 g/Day | Change From Baseline in HbA1c Levels at Day 28 | -0.23 Percentage of HbA1c | Standard Deviation 0.68 |
| SRT2104 0.5 g/Day | Change From Baseline in HbA1c Levels at Day 28 | -0.05 Percentage of HbA1c | Standard Deviation 0.52 |
| SRT2104 1.0 g/Day | Change From Baseline in HbA1c Levels at Day 28 | 0.01 Percentage of HbA1c | Standard Deviation 0.78 |
| SRT2104 2.0 g/Day | Change From Baseline in HbA1c Levels at Day 28 | -0.10 Percentage of HbA1c | Standard Deviation 0.71 |
p-value: 0.94ANOVA
p-value: 0.197ANOVA
p-value: 0.097ANOVA
p-value: 0.404ANOVA
Secondary
Change From Baseline in HOMA-IR at Day 28
HOMA-IR was derived from FPG and FPI as: FPI (mU/mL)\*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.
Time frame: Baseline (Day 1) and Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HOMA-IR at Day 28 | -0.4 mU*mmol per liter^2 | Standard Deviation 3.61 |
| SRT2104 0.25 g/Day | Change From Baseline in HOMA-IR at Day 28 | 0.0 mU*mmol per liter^2 | Standard Deviation 7.26 |
| SRT2104 0.5 g/Day | Change From Baseline in HOMA-IR at Day 28 | -0.9 mU*mmol per liter^2 | Standard Deviation 3.47 |
| SRT2104 1.0 g/Day | Change From Baseline in HOMA-IR at Day 28 | -0.1 mU*mmol per liter^2 | Standard Deviation 3.83 |
| SRT2104 2.0 g/Day | Change From Baseline in HOMA-IR at Day 28 | 1.0 mU*mmol per liter^2 | Standard Deviation 10.17 |
p-value: 0.996ANOVA
p-value: 0.989ANOVA
p-value: 0.999ANOVA
p-value: 0.763ANOVA
Secondary
Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28
HOMA-percentage cell beta function was derived from FPG and FPI as: 20\*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28. Baseline was defined as assessment done on Day 1. Baseline was defined as the assessment done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (Day 28) value.
Time frame: Baseline (Day 1) and Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28 | 5.8 Percentage of beta cell function | Standard Deviation 34.02 |
| SRT2104 0.25 g/Day | Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28 | 8.5 Percentage of beta cell function | Standard Deviation 42.09 |
| SRT2104 0.5 g/Day | Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28 | 2.3 Percentage of beta cell function | Standard Deviation 17.87 |
| SRT2104 1.0 g/Day | Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28 | 3.1 Percentage of beta cell function | Standard Deviation 26.45 |
| SRT2104 2.0 g/Day | Change From Baseline in HOMA-percentage of Beta Cell Function at Day 28 | 7.6 Percentage of beta cell function | Standard Deviation 51.96 |
p-value: 0.994ANOVA
p-value: 0.979ANOVA
p-value: 0.993ANOVA
p-value: 0.999ANOVA
Secondary
Change From Baseline in PPG and PPI Levels at Day 28
The assessment of PPG and PPI was performed at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast) on Day 1 and Day 28. Baseline for PPG was defined as the assessment value of FPG done on Day 1 and Baseline for PPI was defined as the assessment value of FPI done on Day 1. The change from Baseline was calculated by subtracting the Baseline value (Day 1) from the individual post-Baseline (30 min, 60 min and 2 h at Day 28) values.
Time frame: Baseline (Day 1) and Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 30 minutes | 162.4 mmol per liter | Standard Deviation 204.29 |
| Placebo | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 60 minutes | 222.9 mmol per liter | Standard Deviation 206.99 |
| Placebo | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 2 hour | 142.0 mmol per liter | Standard Deviation 113.58 |
| Placebo | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 30 minutes | 3.38 mmol per liter | Standard Deviation 2.85 |
| Placebo | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 60 minutes | 4.53 mmol per liter | Standard Deviation 2.86 |
| Placebo | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 2 hour | 3.56 mmol per liter | Standard Deviation 3.37 |
| SRT2104 0.25 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 60 minutes | 3.92 mmol per liter | Standard Deviation 3.55 |
| SRT2104 0.25 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 2 hour | 2.93 mmol per liter | Standard Deviation 3.33 |
| SRT2104 0.25 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 30 minutes | 108.7 mmol per liter | Standard Deviation 136.13 |
| SRT2104 0.25 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 2 hour | 123.3 mmol per liter | Standard Deviation 253.84 |
| SRT2104 0.25 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 30 minutes | 2.82 mmol per liter | Standard Deviation 2.4 |
| SRT2104 0.25 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 60 minutes | 176.9 mmol per liter | Standard Deviation 278.91 |
| SRT2104 0.5 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 30 minutes | 3.40 mmol per liter | Standard Deviation 2.52 |
| SRT2104 0.5 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 60 minutes | 5.12 mmol per liter | Standard Deviation 2.57 |
| SRT2104 0.5 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 30 minutes | 119.2 mmol per liter | Standard Deviation 157.32 |
| SRT2104 0.5 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 2 hour | 128.7 mmol per liter | Standard Deviation 106.87 |
| SRT2104 0.5 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 60 minutes | 153.9 mmol per liter | Standard Deviation 146.74 |
| SRT2104 0.5 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 2 hour | 4.23 mmol per liter | Standard Deviation 2.88 |
| SRT2104 1.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 30 minutes | 3.14 mmol per liter | Standard Deviation 1.75 |
| SRT2104 1.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 60 minutes | 128.4 mmol per liter | Standard Deviation 105.95 |
| SRT2104 1.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 2 hour | 120.5 mmol per liter | Standard Deviation 129.95 |
| SRT2104 1.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 2 hour | 3.66 mmol per liter | Standard Deviation 2.54 |
| SRT2104 1.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 60 minutes | 4.74 mmol per liter | Standard Deviation 2.34 |
| SRT2104 1.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 30 minutes | 94.9 mmol per liter | Standard Deviation 109.96 |
| SRT2104 2.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 60 minutes | 3.68 mmol per liter | Standard Deviation 3.08 |
| SRT2104 2.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 2 hour | 117.3 mmol per liter | Standard Deviation 127.26 |
| SRT2104 2.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 60 minutes | 121.0 mmol per liter | Standard Deviation 95.22 |
| SRT2104 2.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 2 hour | 3.47 mmol per liter | Standard Deviation 3.44 |
| SRT2104 2.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPG, 30 minutes | 2.00 mmol per liter | Standard Deviation 2.17 |
| SRT2104 2.0 g/Day | Change From Baseline in PPG and PPI Levels at Day 28 | PPI, 30 minutes | 57.4 mmol per liter | Standard Deviation 73.07 |
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 30 minutes.p-value: 0.809ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 30 minutes.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 30 minutes.p-value: 0.989ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 30 minutes.p-value: 0.13ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 60 minutes.p-value: 0.87ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 60 minutes.p-value: 0.864ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 60 minutes.p-value: 0.997ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 60 minutes.p-value: 0.682ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in PPG at 2 hour.p-value: 0.798ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in PPG at 2 hour.p-value: 0.73ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in PPG at 2 hour.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in PPG at 2 hour.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 30 minutes.p-value: 0.464ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 30 minutes.p-value: 0.634ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 30 minutes.p-value: 0.254ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 30 minutes.p-value: 0.034ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 60 minutes.p-value: 0.765ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 60 minutes.p-value: 0.434ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 60 minutes.p-value: 0.184ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 60 minutes.p-value: 0.142ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day for change from Baseline in PPI at 2 hour.p-value: 0.955ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day for change from Baseline in PPI at 2 hour.p-value: 0.985ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day for change from Baseline in PPI at 2 hour.p-value: 0.923ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day for change from Baseline in PPI at 2 hour.p-value: 0.883ANOVA
Secondary
Mean Fasting Plasma Glucose (FPG) Levels Over Time
The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.
Time frame: Up to Day 35
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 22 | 10.03 mmol per liter | Standard Deviation 2.03 |
| Placebo | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 15 | 10.08 mmol per liter | Standard Deviation 2.46 |
| Placebo | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 8 | 10.46 mmol per liter | Standard Deviation 2.6 |
| Placebo | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 35 | 10.10 mmol per liter | Standard Deviation 2.41 |
| Placebo | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 28 | 9.60 mmol per liter | Standard Deviation 2.02 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 35 | 10.10 mmol per liter | Standard Deviation 2.21 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 8 | 10.33 mmol per liter | Standard Deviation 2.3 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 15 | 10.52 mmol per liter | Standard Deviation 2.4 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 22 | 10.31 mmol per liter | Standard Deviation 2.66 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 28 | 10.21 mmol per liter | Standard Deviation 2.12 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 15 | 10.51 mmol per liter | Standard Deviation 2.39 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 22 | 11.24 mmol per liter | Standard Deviation 2.17 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 8 | 11.10 mmol per liter | Standard Deviation 2.33 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 28 | 10.49 mmol per liter | Standard Deviation 2.22 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 35 | 9.92 mmol per liter | Standard Deviation 2.04 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 22 | 10.59 mmol per liter | Standard Deviation 2.35 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 15 | 10.37 mmol per liter | Standard Deviation 2.3 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 28 | 10.32 mmol per liter | Standard Deviation 2.16 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 8 | 10.67 mmol per liter | Standard Deviation 2.19 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 35 | 9.51 mmol per liter | Standard Deviation 2.62 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 28 | 10.05 mmol per liter | Standard Deviation 2.38 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 22 | 10.56 mmol per liter | Standard Deviation 2.84 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 8 | 10.37 mmol per liter | Standard Deviation 2.81 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 35 | 9.03 mmol per liter | Standard Deviation 1.98 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Glucose (FPG) Levels Over Time | Day 15 | 10.41 mmol per liter | Standard Deviation 2.81 |
Comparison: Placebo versus SRT2104 0.25 g/day on Day 8 for FPG.p-value: 0.997ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 8 for FPG.p-value: 0.581ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 8 for FPG.p-value: 0.987ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 8 for FPG.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 15 for FPG.p-value: 0.85ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 15 for FPG.p-value: 0.843ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 15 for FPG.p-value: 0.961ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 15 for FPG.p-value: 0.939ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 22 for FPG.p-value: 0.966ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 22 for FPG.p-value: 0.075ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 22 for FPG.p-value: 0.7ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 22 for FPG.p-value: 0.732ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 28 for FPG.p-value: 0.552ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 28 for FPG.p-value: 0.196ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 28 for FPG.p-value: 0.393ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 28 for FPG.p-value: 0.775ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 35 for FPG.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 35 for FPG.p-value: 0.989ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 35 for FPG.p-value: 0.603ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 35 for FPG.p-value: 0.108ANOVA
Secondary
Mean Fasting Plasma Insulin (FPI) Levels Over Time
The assessments were done at Day 1, Day 8, Day 15, Day 22, Day 28 and Day 35 weekly at central laboratory. The analysis was reported for Day 8, Day 15, Day 22, Day 28 and Day 35.
Time frame: Up to Day 35
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 22 | 98.7 mmol per liter | Standard Deviation 98.55 |
| Placebo | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 15 | 90.0 mmol per liter | Standard Deviation 70.89 |
| Placebo | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 35 | 101.6 mmol per liter | Standard Deviation 70.49 |
| Placebo | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 28 | 82.4 mmol per liter | Standard Deviation 56.91 |
| Placebo | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 8 | 89.9 mmol per liter | Standard Deviation 59.63 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 22 | 74.3 mmol per liter | Standard Deviation 93.51 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 8 | 92.3 mmol per liter | Standard Deviation 95.57 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 15 | 78.4 mmol per liter | Standard Deviation 93.5 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 28 | 91.7 mmol per liter | Standard Deviation 118.05 |
| SRT2104 0.25 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 35 | 110.5 mmol per liter | Standard Deviation 157.53 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 35 | 87.1 mmol per liter | Standard Deviation 56.22 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 22 | 81.8 mmol per liter | Standard Deviation 47.79 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 28 | 63.7 mmol per liter | Standard Deviation 44.87 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 15 | 80.4 mmol per liter | Standard Deviation 45.86 |
| SRT2104 0.5 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 8 | 83.8 mmol per liter | Standard Deviation 52.19 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 15 | 80.5 mmol per liter | Standard Deviation 76.39 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 8 | 74.5 mmol per liter | Standard Deviation 61.77 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 22 | 78.8 mmol per liter | Standard Deviation 65.46 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 35 | 84.0 mmol per liter | Standard Deviation 78.95 |
| SRT2104 1.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 28 | 63.3 mmol per liter | Standard Deviation 55.69 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 28 | 89.2 mmol per liter | Standard Deviation 134.56 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 35 | 115.3 mmol per liter | Standard Deviation 213.37 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 22 | 76.8 mmol per liter | Standard Deviation 57.34 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 8 | 74.4 mmol per liter | Standard Deviation 51.36 |
| SRT2104 2.0 g/Day | Mean Fasting Plasma Insulin (FPI) Levels Over Time | Day 15 | 79.3 mmol per liter | Standard Deviation 89.05 |
Comparison: Placebo versus SRT2104 0.5 g/day on Day 8 for FPI.p-value: 0.982ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 8 for FPI.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 8 for FPI.p-value: 0.677ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 8 for FPI.p-value: 0.688ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 15 for FPI.p-value: 0.903ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 15 for FPI.p-value: 0.945ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 15 for FPI.p-value: 0.949ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 15 for FPI.p-value: 0.924ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 22 for FPI.p-value: 0.394ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 22 for FPI.p-value: 0.687ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 22 for FPI.p-value: 0.568ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 22 for FPI.p-value: 0.486ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 28 for FPI.p-value: 0.973ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 28 for FPI.p-value: 0.739ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 28 for FPI.p-value: 0.731ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 28 for FPI.p-value: 0.991ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day on Day 35 for FPI.p-value: 0.994ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day on Day 35 for FPI.p-value: 0.963ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day on Day 35 for FPI.p-value: 0.929ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day on Day 35 for FPI.p-value: 0.97ANOVA
Secondary
Mean Fructosamine Levels at Day 1 and Day 28
Fructosamine (a glycated protein) level enables assessment of long-term glycemic control in participants with diabetes mellitus. The blood samples for fructosamine assessment was obtained at Day 1 and Day 28.
Time frame: Day 1 and Day 28
Population: ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Fructosamine Levels at Day 1 and Day 28 | Day 1 | 320.07 mmol/L | Standard Deviation 61.28 |
| Placebo | Mean Fructosamine Levels at Day 1 and Day 28 | Day 28 | 305.70 mmol/L | Standard Deviation 56.04 |
| SRT2104 0.25 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 1 | 320.38 mmol/L | Standard Deviation 49.2 |
| SRT2104 0.25 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 28 | 315.97 mmol/L | Standard Deviation 60.46 |
| SRT2104 0.5 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 1 | 319.82 mmol/L | Standard Deviation 56.73 |
| SRT2104 0.5 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 28 | 330.15 mmol/L | Standard Deviation 61.32 |
| SRT2104 1.0 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 28 | 318.63 mmol/L | Standard Deviation 50.9 |
| SRT2104 1.0 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 1 | 328.44 mmol/L | Standard Deviation 62.9 |
| SRT2104 2.0 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 1 | 296.00 mmol/L | Standard Deviation 41.86 |
| SRT2104 2.0 g/Day | Mean Fructosamine Levels at Day 1 and Day 28 | Day 28 | 285.28 mmol/L | Standard Deviation 57.45 |
Comparison: Placebo versus SRT2104 0.25 g/day at Day 1 for fructosamine.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at Day 1 for fructosamine.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at Day 1 for fructosamine.p-value: 0.901ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at Day 1 for fructosamine.p-value: 0.155ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at Day 28 for fructosamine.p-value: 0.845ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at Day 28 for fructosamine.p-value: 0.164ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at Day 28 for fructosamine.p-value: 0.699ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at Day 28 for fructosamine.p-value: 0.313ANOVA
Secondary
Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28
The sample for HbA1c assessment was collected on Day 28. HbA1c is used to show how well their diabetes is being controlled in participants with diabetes. The HbA1c test gives the average blood glucose levels over the pervious two to three months.
Time frame: Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28 | 8.18 Percentage of HbA1c | Standard Deviation 0.95 |
| SRT2104 0.25 g/Day | Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28 | 8.66 Percentage of HbA1c | Standard Deviation 1 |
| SRT2104 0.5 g/Day | Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28 | 8.64 Percentage of HbA1c | Standard Deviation 0.93 |
| SRT2104 1.0 g/Day | Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28 | 8.54 Percentage of HbA1c | Standard Deviation 1.16 |
| SRT2104 2.0 g/Day | Mean Glycosylated Hemoglobin A (HbA1c) Levels on Day 28 | 8.29 Percentage of HbA1c | Standard Deviation 0.9 |
p-value: 0.118ANOVA
p-value: 0.119ANOVA
p-value: 0.293ANOVA
p-value: 0.966ANOVA
Secondary
Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28
HOMA-percentage cell beta function was derived from FPG and FPI as: 20\*FPI (mU/mL) divided by FPG (mmol per liter) minus 3.5. HOMA-percentage cell beta function was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.
Time frame: Day 1 and Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 1 | 38.3 Percentage of beta cell function | Standard Deviation 38.15 |
| Placebo | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 28 | 42.9 Percentage of beta cell function | Standard Deviation 34.71 |
| SRT2104 0.25 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 1 | 31.8 Percentage of beta cell function | Standard Deviation 46.38 |
| SRT2104 0.25 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 28 | 42.9 Percentage of beta cell function | Standard Deviation 57.9 |
| SRT2104 0.5 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 1 | 31.2 Percentage of beta cell function | Standard Deviation 35.46 |
| SRT2104 0.5 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 28 | 32.6 Percentage of beta cell function | Standard Deviation 34.57 |
| SRT2104 1.0 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 28 | 28.4 Percentage of beta cell function | Standard Deviation 26.48 |
| SRT2104 1.0 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 1 | 27.2 Percentage of beta cell function | Standard Deviation 21.39 |
| SRT2104 2.0 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 1 | 30.2 Percentage of beta cell function | Standard Deviation 23.03 |
| SRT2104 2.0 g/Day | Mean HOMA-percentage Cell Beta Function at Day 1 and Day 28 | Day 28 | 40.9 Percentage of beta cell function | Standard Deviation 48.31 |
Comparison: Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-percentage of beta cell function.p-value: 0.81ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-percentage of beta cell function.p-value: 0.753ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-percentage of beta cell function.p-value: 0.404ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-percentage of beta cell function.p-value: 0.671ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-percentage of beta cell function.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-percentage of beta cell function.p-value: 0.622ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-percentage of beta cell function.p-value: 0.332ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-percentage of beta cell function.p-value: 0.998ANOVA
Secondary
Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28
HOMA-IR was derived from FPG and FPI as: FPI (micro units \[mU\]/mL)\*FPG (mmol per liter) divided by 22.5. HOMA-IR was calculated from the Day 1 and Day 28 FPG and FPI values at Day 1 and Day 28.
Time frame: Day 1 and Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 1 | 5.4 mU*mmol per liter^2 | Standard Deviation 3.98 |
| Placebo | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 28 | 4.9 mU*mmol per liter^2 | Standard Deviation 3.56 |
| SRT2104 0.25 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 28 | 5.9 mU*mmol per liter^2 | Standard Deviation 7.28 |
| SRT2104 0.25 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 1 | 5.7 mU*mmol per liter^2 | Standard Deviation 5.45 |
| SRT2104 0.5 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 28 | 3.9 mU*mmol per liter^2 | Standard Deviation 2.55 |
| SRT2104 0.5 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 1 | 5.2 mU*mmol per liter^2 | Standard Deviation 5.2 |
| SRT2104 1.0 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 1 | 4.1 mU*mmol per liter^2 | Standard Deviation 3.31 |
| SRT2104 1.0 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 28 | 4.0 mU*mmol per liter^2 | Standard Deviation 3.66 |
| SRT2104 2.0 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 28 | 5.9 mU*mmol per liter^2 | Standard Deviation 10.1 |
| SRT2104 2.0 g/Day | Mean Homeostatic Model Assessment-insulin Resistance (HOMA-IR) at Day 1 and Day 28 | Day 1 | 5.0 mU*mmol per liter^2 | Standard Deviation 3.75 |
Comparison: Placebo versus SRT2104 0.25 g/day at Day 1 for HOMA-IR.p-value: 0.992ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at Day 1 for HOMA-IR.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at Day 1 for HOMA-IR.p-value: 0.548ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at Day 1 for HOMA-IR.p-value: 0.989ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at Day 28 for HOMA-IR.p-value: 0.877ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at Day 28 for HOMA-IR.p-value: 0.887ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at Day 28 for HOMA-IR.p-value: 0.916ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at Day 28 for HOMA-IR.p-value: 0.86ANOVA
Secondary
Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28
The assessment of PPG and PPI was performed on Day 28 at 30 minutes, 60 minutes and 2 hour after the participant consumed the standardized meal (morning breakfast).
Time frame: Day 28
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 30 minutes | 237.6 mmol per liter | Standard Deviation 222.95 |
| Placebo | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 60 minutes | 14.05 mmol per liter | Standard Deviation 3.13 |
| Placebo | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 2 hour | 224.4 mmol per liter | Standard Deviation 129.69 |
| Placebo | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 60 minutes | 298.1 mmol per liter | Standard Deviation 232.43 |
| Placebo | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 2 hour | 13.16 mmol per liter | Standard Deviation 4.26 |
| Placebo | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 30 minutes | 12.91 mmol per liter | Standard Deviation 2.94 |
| SRT2104 0.25 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 2 hour | 13.15 mmol per liter | Standard Deviation 3.55 |
| SRT2104 0.25 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 30 minutes | 217.2 mmol per liter | Standard Deviation 198.91 |
| SRT2104 0.25 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 30 minutes | 12.95 mmol per liter | Standard Deviation 2.66 |
| SRT2104 0.25 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 2 hour | 215.0 mmol per liter | Standard Deviation 309.78 |
| SRT2104 0.25 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 60 minutes | 285.4 mmol per liter | Standard Deviation 339.9 |
| SRT2104 0.25 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 60 minutes | 14.05 mmol per liter | Standard Deviation 3.57 |
| SRT2104 0.5 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 60 minutes | 15.44 mmol per liter | Standard Deviation 3.05 |
| SRT2104 0.5 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 30 minutes | 13.58 mmol per liter | Standard Deviation 3.05 |
| SRT2104 0.5 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 2 hour | 14.74 mmol per liter | Standard Deviation 3.15 |
| SRT2104 0.5 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 30 minutes | 188.3 mmol per liter | Standard Deviation 172.53 |
| SRT2104 0.5 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 60 minutes | 223.0 mmol per liter | Standard Deviation 167.72 |
| SRT2104 0.5 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 2 hour | 192.5 mmol per liter | Standard Deviation 132.93 |
| SRT2104 1.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 2 hour | 183.8 mmol per liter | Standard Deviation 160.2 |
| SRT2104 1.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 30 minutes | 13.12 mmol per liter | Standard Deviation 2.9 |
| SRT2104 1.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 60 minutes | 14.77 mmol per liter | Standard Deviation 3.16 |
| SRT2104 1.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 60 minutes | 189.2 mmol per liter | Standard Deviation 145.83 |
| SRT2104 1.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 2 hour | 13.90 mmol per liter | Standard Deviation 3.6 |
| SRT2104 1.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 30 minutes | 160.2 mmol per liter | Standard Deviation 153.46 |
| SRT2104 2.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 2 hour | 206.4 mmol per liter | Standard Deviation 202.4 |
| SRT2104 2.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 30 minutes | 163.0 mmol per liter | Standard Deviation 179.83 |
| SRT2104 2.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 60 minutes | 13.08 mmol per liter | Standard Deviation 3.7 |
| SRT2104 2.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 30 minutes | 11.41 mmol per liter | Standard Deviation 2.77 |
| SRT2104 2.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPI, 60 minutes | 226.6 mmol per liter | Standard Deviation 200.82 |
| SRT2104 2.0 g/Day | Mean Post-prandial Glucose (PPG) and Post-prandial Insulin (PPI) Levels at Day 28 | PPG, 2 hour | 13.61 mmol per liter | Standard Deviation 4.43 |
Comparison: Placebo versus SRT2104 0.25 g/day at 30 minutes for PPG.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at 30 minutes for PPG.p-value: 0.812ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at 30 minutes for PPG.p-value: 0.996ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at 30 minutes for PPG.p-value: 0.198ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at 60 minutes for PPG.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at 60 minutes for PPG.p-value: 0.358ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at 60 minutes for PPG.p-value: 0.852ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at 60 minutes for PPG.p-value: 0.678ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at 2 hour for PPG.p-value: 1ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at 2 hour for PPG.p-value: 0.191ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at 2 hour for PPG.p-value: 0.805ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at 2 hour for PPG.p-value: 0.96ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at 30 minutes for PPI.p-value: 0.985ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at 30 minutes for PPI.p-value: 0.733ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at 30 minutes for PPI.p-value: 0.365ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at 30 minutes for PPI.p-value: 0.413ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at 60 minutes for PPI.p-value: 0.765ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at 60 minutes for PPI.p-value: 0.434ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at 60 minutes for PPI.p-value: 0.184ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at 60 minutes for PPI.p-value: 0.142ANOVA
Comparison: Placebo versus SRT2104 0.25 g/day at 2 hour for PPI.p-value: 0.999ANOVA
Comparison: Placebo versus SRT2104 0.5 g/day at 2 hour for PPI.p-value: 0.876ANOVA
Comparison: Placebo versus SRT2104 1.0 g/day at 2 hour for PPI.p-value: 0.756ANOVA
Comparison: Placebo versus SRT2104 2.0 g/day at 2 hour for PPI.p-value: 0.983ANOVA