Cancer, Neoplasms
Conditions
Keywords
pharmacokinetics, TLR4 agonist, cancer, tolerability, GSK1795091, pharmacodynamics, safety
Brief summary
This study is an ascending dose first-time-in-human study to determine the safety, tolerability, pharmacodynamic (PD), and pharmacokinetics (PK) profile of GSK1795091 in healthy subjects. The results will support the design of future clinical trials of GSK1795091 administered to subjects with advanced malignancies in combination with immune system modulators. Part 1 will be a randomized, double-blind (sponsor-unblinded), placebo-controlled, single center, single dose escalation, sequential group evaluation of intravenously administered GSK1795091 to evaluate the safety and tolerability in healthy subjects. Part 2 will be an open-label, parallel group evaluation of 2 doses of GSK1795091 administered, either 1 week apart (Part 2, Cohort 1) or 2 weeks apart (Part 2, Cohort 2). In Part 2, on Day 1, subjects will receive intravenous GSK1795091 at a dose determined by results from Part 1. The total duration of this study is approximately 10 weeks from screening to the last study visit.
Interventions
DRUGGSK1795091
GSK1795091 will be supplied as solution for injection vial. Each 5 mL vial contains 0.001 milligram/mL (mg/mL; 1000 ng/mL) or 0.0001 mg/mL (100 ng/mL)of GSK1795091 and will be administered as IV bolus over 2-5 minutes (min) followed by a IV bolus of 10 mL normal saline.
DRUGPlacebo
Matching placebo will be supplied as a solution for injection vial and will be administered as IV bolus over 2-5 min followed by a IV bolus of 10 mL normal saline
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 18 and 50 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECG. (A subject with a clinically insignificant abnormality or laboratory parameter(s) may be included only if the Investigator documents that the finding is unlikely to represent a safety risk and will not interfere with the study procedures.) * Body weight 55-95 kilogram (kg) and body mass index within the range 19-30 kg/meter (m)\^2 (inclusive). * Male or Female of non-childbearing potential: Males: Male subjects with female partners of child bearing potential must comply with the pre specified contraception requirements. Females: A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum or urine human chorionic gonadotropin test), not lactating, and is either of non-reproductive potential or reproductive potential. If of reproductive potential, then the subject should agree to follow one of the options listed per GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential from 30 days prior to the first dose and until 30 days after the last dose of study medication The Investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception * Capable of giving signed informed consent
Exclusion criteria
* History of any significant medical condition (e.g. cardiac, pulmonary, metabolic, renal, gastrointestinal, rheumatological, etc.) * History of frequent (\>1 per week) headache or myalgia, asthma, syncope. * History of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome). * Alanine aminotransferase (ALT) and bilirubin \>1.1×upper limit of normal (ULN; isolated bilirubin \>1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * Vital signs: Systolic blood pressure (SBP) \<90 and \>140 milliliter of mercury (mmHg); diastolic BP \<50 and \>90 mmHg; heart rate (HR) \<50 and \>90 beats per minute (bpm); temperature \>37.5 degree Celsius * Clinically significant ECG abnormality and/or HR \< 50 and \>90 bpm; PR interval \>220 milliseconds (msec); QRS duration \>120 msec; and QTcF \> 450 msec * Anticipated requirement for any prescription medication during the study * History of regular alcohol consumption within 6 months of the study averaging a weekly intake of \>14 drinks for males or \>7 drinks for females or inability to abstain from alcohol from 1 day prior to the inpatient period of the study until discharge (one drink is equivalent to 8 grams of alcohol: 200 milliliter \[mL\] of beer, 100 mL of wine or 1 measure (25 mL) of spirits) * Urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 2 months prior to screening or inability to abstain from smoking during the study * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation * Presence of hepatitis B surface antigen, positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. Subjects with positive Hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C ribonucleic acid polymerase chain reaction test is obtained. * A positive pre-study drug/alcohol screen. * A positive test for human immunodeficiency antivirus antibody. * Donation of blood or blood products in excess of 500 mL within a 56-day period. * The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first visit (Day -2) in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). * Exposure to more than four new chemical entities within 12 months prior to the first visit (Day -2). * Exposure to GSK1795091 in a previous cohort of this study. * Subject is unable to refrain from taking non-prescription drugs (including vitamins and dietary or herbal supplements), within 7 days prior to the first dose of study medication until completion of the follow-up visit, unless in the opinion of the investigator and sponsor, the medication will not interfere with the study. * Subject is able to understand and communicate in German/or native language of the site. Subject, or close relative of the subject, is the investigator or a sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study at that site * Vulnerable subjects (eg subjects kept in detention)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Up to Day 32 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants enrolled into the study who have received a dose of study medication (GSK1795091 or placebo) were included in the All Subjects Population. Participants with non-serious AEs (5 percentage threshold) and SAEs has been reported. |
| Change From Baseline in Body Temperature Part 1 | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | Body temperature was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. |
| Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | Systolic and diastolic BP was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. |
| Change From Baseline in Pulse Rate Part 1 | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. |
| Change From Baseline in Respiratory Rate Part 1 | Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7. | Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. |
| Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Up to Day 7 | Hematology parameters included hemoglobin (HGB), hematocrit (HCT), Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Reference range for basophil was 0.01 - 0.07\*10\^9/Liters (L), eosinophils 0.03 - 0.5\*10\^9/L, HCT 0.38 - 0.48 proportion of RBC in blood, HGB 126 - 165\*gram (g)/L, lymphocytes 1.08 - 3\*10\^9/L, MCH 26.3 - 32.8\*picogram (pg), MCHC 324 - 359\*g/L, MCV 77 - 94.9\*femtoliter (fL), monocytes 0.3 - 0.92\*10\^9/L, neutrophils 1.46 - 5.85\*10\^9/L, platelets 155 - 342\*10\^9/L, erythrocytes 4.12 - 5.74\*10\^12/L, leukocytes 3.19 - 8.71\*10\^9/L. Values below these ranges were considered as low and above these ranges were considered as high (H). Data for participants from any visit post-screening with values \> reference range high and \< reference range low are report. |
| Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Up to Day 7 | Clinical chemistry parameters with reference range were albumin 35-52\*g/L, Alkaline phosphatase (ALP) 30-120\*International units/L (IU/L), Alanine aminotransferase (ALT) 0-50 \* IU/L, Aspartate aminotransferase (AST) 0-50\*IU/L, direct bilirubin 0-3.4\* micromoles/L (µmol/L), bilirubin 5-21\*µmol/L, calcium 2.2-2.65\* millimoles/L (mmol/L), cholesterol 0-5.19\* mmol/L, creatinine 59-104\* µmol/L, C-reactive protein (CRP) 0-5\*milligram (mg)/L,Gamma Glutamyl Transferase (GGT) 4.1-5.9\*mmol/L, high density lipoproteins (HDL) cholesterol 0.99-2.32\*mmol/L, potassium 3.5-5.1\*mmol/L, low density lipoproteins (LDL) cholesterol 0-3.3\*mmol/L, protein 66-83\*g/L, sodium 136-146 \* mmol/L, triglycerides 0-2.25 \* mmol/L, glucose 4.1-5.9\*mmol/L, and urea 2.8-7.2\*mmol/L. Values below these ranges were considered as low and above these ranges were considered as high. Data for participants from any visit post-screening with values \> reference range high and \< reference range low are reported. |
| Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | Urinalysis included microscopic examination parameters like Casts, REC, SEC, Urine erythrocytes and Urine leukocytes. Data at indicated time points were reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point. |
| Ketones and Urine Glucose at Indicated Time Points | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | Urinalysis included parameters like ketones and urine glucose. Data at indicated time points were reported. |
| Occult Blood at Indicated Time Points | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | Urinalysis included parameter like Occult blood. Data at indicated time points were reported. |
| Urine Protein at Indicated Time Points | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | Urinalysis included parameter like Urine protein. Data at indicated time points were reported. |
| Specific Gravity at Indicated Time Points | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | Urinalysis included parameter like specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. |
| Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7 | Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). |
| Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | Up to Day 32 | Single measurements of 12-lead ECGs were obtained after 10 minutes of rest in a semi-supine position for the participant. Participants with abnormal ECG findings that are clinically not significant (NCS) and clinically significant (CS) data has been presented here. The data of worst case post-Baseline is presented here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in CRP for Part 1 | Baseline, Days 2, 4 and 7 | Blood samples were collected at indicated time points for the assessment of CRP. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. |
| Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Cmax assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of Adverse events (AEs) of unknown etiology. |
| Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Tmax and t1/2 assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Partial Area Under the Concentration-time Curve to Time = t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | AUC (0-t) and AUC (0-inf) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Area Under the Concentration-time Curve (AUC) Time Curve for a Dosing Interval (AUC[0-tau]), AUC (0-last) of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | AUC (0-tau) and AUC (0-last) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Clearance (CL) of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | CL assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Volume of Distribution of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Volume of distribution assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Accumulation Ratio of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Accumulation ratio assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Time Invariance of GSK1795091 for Part 2 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Time invariance assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | IL-6 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of TNF-alpha From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | TNF-alpha assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of IFN-gamma From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | IFN-gamma assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of IP-10 From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | IP-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of MCP-1 From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | MCP-1 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of GCSF From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | GCSF assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of IL-1Ra From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | IL-1Ra assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Percentage Fold Change of Concentration of IL-10 From Baseline for Part 2 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | IL-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Change From Baseline in WBC Differential for Part 2 | Baseline, 2, 24 and 144 hours | WBC differential assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Number of Participants With Urinalysis Parameters Outside Reference Range for Part 2 | Up to Day 7 | Urinalysis as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated for each participant using a non-compartmental method. All participants for whom, at least, one valid and evaluable pharmacokinetic parameter (AUC or Cmax) was derived were included in PK Parameter Population. Only those participants with data available at the specified data points were analyzed. |
| Number of Participants With Clinical Chemistry Parameters Outside Reference Range in Part 2 | Up to Day 7 | Clinical chemistry as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Change From Baseline in CRP for Part 2 | Baseline and Pre-dose, 1, 2, 4, 8, 12, 16, 24, and 48 hours post dose | CRP assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Change From Baseline in Body Temperature for Part 2 | Baseline and up to Day 7 | Body temperature was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Change From Baseline in SBP and DBP for Part 2 | Baseline and up to Day 7 | SBP and DBP was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Change From Baseline in Respiratory Rate for Part 2 | Baseline and up to Day 7 | Respiratory rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Change From Baseline in Pulse Rate for Part 2 | Baseline and up to Day 7 | Pulse rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Number of Participants With Hematology Parameters Outside Reference Range in Part 2 | Up to Day 7 | Hematology as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology. |
| Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed. |
| Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. AUC (0-t) was used interchangeably with AUC to last time of quantifiable concentration (AUC\[0-last\]) .Only those participants with data available at the specified data points were analyzed. |
| Clearance (CL) of GSK1795091 for Part 1 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed. |
| Volume of Distribution of GSK1795091 for Part 1 | Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose | Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed. |
| Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of IL-6. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. All participants in the All Subjects Population for whom valid and evaluable pharmacodynamic parameters were derived are included in Pharmacodynamic (PD) Population. Data from multiplex immunoassay has been reported. |
| Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of TNF-alpha. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). |
| Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of IFN-gamma. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). |
| Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of IP-10. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. |
| Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. |
| Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of GCSF. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. |
| Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of IL-1Ra. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. |
| Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours | Blood samples were collected at indicated time points for the assessment of IL-10. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. |
| Change From Baseline in WBC Differential for Part 1 | Baseline, 4, 24 and 144 hours | WBC differential included Lymphocytes Count, Monocytes Count, Granulocytes Count including neutrophils and eosinophil. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). |
Countries
Germany
Participant flow
Recruitment details
This study was planned to be conducted in 2-parts, however Part 2 was discontinued by the Sponsor prior to its scheduled start. Part 1 was single-dose escalation, sequential group evaluation of intravenously administered GSK1795091 to evaluate the safety and tolerability in healthy participants.
Pre-assignment details
Forty two participants were randomized in Part 1 of which 2 did not receive dose due to abnormal findings during pre-dose examination. Participants were randomized in ratio of 3:1 to receive GSK1795091 or matching placebo.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Placebo Participants in Part 1 were randomized to receive intravenous (IV) matching Placebo of GSK1795091. Participants were observed inpatient until discharge on Day 5. | 10 |
| Part 1: GSK1795091 7 ng In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 7 nanogram (ng). Participants were observed inpatient until discharge on Day 5. | 6 |
| Part 1: GSK1795091 21 ng In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 21 ng. Participants were observed inpatient until discharge on Day 5. | 6 |
| Part 1: GSK1795091 60 ng In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 60 ng. Participants were observed inpatient until discharge on Day 5. | 6 |
| Part 1: GSK1795091 Repeated 60 ng In Part one sequential group evaluation, participants were randomized to receive single IV repeat dose of GSK1795091 60 ng as the study was restarted. Participants were observed inpatient until discharge on Day 5. | 6 |
| Part 1: GSK1795091 100 ng In Part one sequential group evaluation, participants were randomized to receive single IV dose of GSK1795091 100 ng. Participants were observed inpatient until discharge on Day 5. | 6 |
| All Participants in Part 2 In part 2, two doses GSK1795091 determined by results from Part 1 were planned in parallel group evaluation. Part 2 was discontinued by the Sponsor prior to its scheduled start and no participants were enrolled. | 0 |
| Total | 40 |
Baseline characteristics
| Characteristic | Part 1: Placebo | Part 1: GSK1795091 7 ng | Part 1: GSK1795091 21 ng | Part 1: GSK1795091 60 ng | Part 1: GSK1795091 Repeated 60 ng | Part 1: GSK1795091 100 ng | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 35.2 Years STANDARD_DEVIATION 8.42 | 30.2 Years STANDARD_DEVIATION 6.62 | 40.5 Years STANDARD_DEVIATION 7.64 | 39.7 Years STANDARD_DEVIATION 7.47 | 43.3 Years STANDARD_DEVIATION 8.43 | 38.3 Years STANDARD_DEVIATION 6.02 | 37.6 Years STANDARD_DEVIATION 8.21 |
| Race/Ethnicity, Customized Row 2 Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Row 2 White/Caucasian/European Heritage | 9 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 38 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 10 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 39 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 | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 0 |
| other Total, other adverse events | 0 / 10 | 2 / 6 | 0 / 6 | 5 / 6 | 3 / 6 | 5 / 6 | 0 / 0 |
| serious Total, serious adverse events | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 0 |
Outcome results
Primary
Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points
Urinalysis included microscopic examination parameters like Casts, REC, SEC, Urine erythrocytes and Urine leukocytes. Data at indicated time points were reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). NA indicates standard deviation could not be calculated as only 1 participant was analyzed at the given time point.
Time frame: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 7, n=4,0,2,2,0,0 | 1.5 Cells per high power field | Standard Deviation 3 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 7, n=4,0,2,2,0,0 | 0.5 Cells per high power field | Standard Deviation 1 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 2.3 Cells per high power field | Standard Deviation 4.04 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 4, n=3,0,1,2,0,0 | 1.0 Cells per high power field | Standard Deviation 1.73 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 2 , n=1,0,3,1,1,2 | 1.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 1.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 1.0 Cells per high power field | Standard Deviation 1.73 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 4, n=3,0,1,2,0,0 | 1.0 Cells per high power field | Standard Deviation 1 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 5.0 Cells per high power field | Standard Deviation 8.66 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 1, Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 2, n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 7, n=4,0,2,2,0,0 | 0.3 Cells per high power field | Standard Deviation 0.5 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: Placebo | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 5.0 Cells per high power field | — |
| Part 1: GSK1795091 7 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 1, Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 7 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 7 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 7 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 7 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.5 Cells per high power field | Standard Deviation 0.71 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 4, n=3,0,1,2,0,0 | 3.0 Cells per high power field | — |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 4.0 Cells per high power field | Standard Deviation 5.66 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 2, n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 4, n=3,0,1,2,0,0 | 2.0 Cells per high power field | — |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.5 Cells per high power field | Standard Deviation 0.71 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 2.0 Cells per high power field | Standard Deviation 2.83 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 1.5 Cells per high power field | Standard Deviation 2.12 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 4, n=3,0,1,2,0,0 | 10.0 Cells per high power field | — |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 1, Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 2, n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 4, n=3,0,1,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 8.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 4, n=3,0,1,2,0,0 | 1.0 Cells per high power field | Standard Deviation 1.41 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 7, n=4,0,2,2,0,0 | 11.0 Cells per high power field | Standard Deviation 12.73 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 3.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 2 , n=1,0,3,1,1,2 | 7.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 7, n=4,0,2,2,0,0 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 1.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 2 , n=1,0,3,1,1,2 | 4.0 Cells per high power field | — |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 4, n=3,0,1,2,0,0 | 42.0 Cells per high power field | Standard Deviation 59.4 |
| Part 1: GSK1795091 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 7, n=4,0,2,2,0,0 | 40.5 Cells per high power field | Standard Deviation 55.86 |
| Part 1: GSK1795091 Repeated 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 Repeated 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 Repeated 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 Repeated 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 Repeated 60 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 2, n=1,0,3,1,1,2 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 3.0 Cells per high power field | Standard Deviation 2.83 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | REC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 1, Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day 2 , n=1,0,3,1,1,2 | 0.5 Cells per high power field | Standard Deviation 0.71 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day 2, n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 2 , n=1,0,3,1,1,2 | 0.5 Cells per high power field | Standard Deviation 0.71 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day 1 Pre-dose, n=3,1,2,0,0,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Erythrocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 1.0 Cells per high power field | — |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 2 , n=1,0,3,1,1,2 | 0.0 Cells per high power field | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day 1 Pre-dose, n=3,1,2,0,0,2 | 1.5 Cells per high power field | Standard Deviation 0.71 |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Casts, Day -1 Pre-dose, n=1,0,2,1,0,1 | 0.0 Cells per high power field | — |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | Urine Leukocytes,Day -1 Pre-dose, n=1,0,2,1,0,1 | 4.0 Cells per high power field | — |
| Part 1: GSK1795091 100 ng | Casts, Round Epithelial Cells (REC), Squamous Epithelial Cells (SEC), Urine Erythrocytes and Urine Leukocytes at Indicated Time Points | SEC, Day -1 Pre-dose, n=1,0,2,1,0,1 | 3.0 Cells per high power field | — |
Primary
Change From Baseline in Body Temperature Part 1
Body temperature was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Time frame: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.
Population: All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 16 hour | 0.03 Celsius | Standard Deviation 0.258 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 2 | 0.06 Celsius | Standard Deviation 0.19 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 12 hour | 0.14 Celsius | Standard Deviation 0.255 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 1 hour | 0.14 Celsius | Standard Deviation 0.084 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 5 | 0.14 Celsius | Standard Deviation 0.178 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 2 hour | 0.17 Celsius | Standard Deviation 0.095 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 4 hour | 0.26 Celsius | Standard Deviation 0.196 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 6 hour | 0.43 Celsius | Standard Deviation 0.206 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 4 | 0.01 Celsius | Standard Deviation 0.197 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 1, 8 hour | 0.41 Celsius | Standard Deviation 0.197 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 7 | 0.02 Celsius | Standard Deviation 0.199 |
| Part 1: Placebo | Change From Baseline in Body Temperature Part 1 | Day 3 | -0.10 Celsius | Standard Deviation 0.221 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 7 | 0.12 Celsius | Standard Deviation 0.204 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 3 | 0.07 Celsius | Standard Deviation 0.207 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 2 hour | 0.23 Celsius | Standard Deviation 0.163 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 4 | 0.25 Celsius | Standard Deviation 0.259 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 8 hour | 0.53 Celsius | Standard Deviation 0.273 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 4 hour | 0.42 Celsius | Standard Deviation 0.147 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 12 hour | 0.18 Celsius | Standard Deviation 0.337 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 6 hour | 0.53 Celsius | Standard Deviation 0.301 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 16 hour | 0.02 Celsius | Standard Deviation 0.223 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 2 | -0.02 Celsius | Standard Deviation 0.172 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 1 hour | 0.17 Celsius | Standard Deviation 0.163 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Body Temperature Part 1 | Day 5 | 0.22 Celsius | Standard Deviation 0.147 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 7 | -0.13 Celsius | Standard Deviation 0.314 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 3 | -0.17 Celsius | Standard Deviation 0.225 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 12 hour | 0.28 Celsius | Standard Deviation 0.397 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 16 hour | -0.08 Celsius | Standard Deviation 0.319 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 2 hour | 0.32 Celsius | Standard Deviation 0.232 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 8 hour | 0.43 Celsius | Standard Deviation 0.301 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 4 | -0.15 Celsius | Standard Deviation 0.217 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 5 | -0.12 Celsius | Standard Deviation 0.194 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 2 | -0.05 Celsius | Standard Deviation 0.226 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 1 hour | 0.08 Celsius | Standard Deviation 0.264 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 4 hour | 0.55 Celsius | Standard Deviation 0.389 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 6 hour | 0.45 Celsius | Standard Deviation 0.464 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 4 hour | 0.98 Celsius | Standard Deviation 0.556 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 8 hour | 0.63 Celsius | Standard Deviation 0.432 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 1 hour | 0.15 Celsius | Standard Deviation 0.187 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 2 hour | 0.68 Celsius | Standard Deviation 0.354 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 6 hour | 0.82 Celsius | Standard Deviation 0.665 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 12 hour | 0.28 Celsius | Standard Deviation 0.397 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 16 hour | 0.03 Celsius | Standard Deviation 0.175 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 2 | 0.12 Celsius | Standard Deviation 0.147 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 3 | 0.10 Celsius | Standard Deviation 0.179 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 4 | 0.05 Celsius | Standard Deviation 0.266 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 5 | 0.17 Celsius | Standard Deviation 0.273 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Body Temperature Part 1 | Day 7 | 0.08 Celsius | Standard Deviation 0.354 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 6 hour | 0.38 Celsius | Standard Deviation 0.483 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 1 hour | 0.15 Celsius | Standard Deviation 0.281 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 4 hour | 0.63 Celsius | Standard Deviation 0.383 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 7 | -0.20 Celsius | Standard Deviation 0.415 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 5 | -0.13 Celsius | Standard Deviation 0.25 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 2 hour | 0.40 Celsius | Standard Deviation 0.179 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 8 hour | 0.57 Celsius | Standard Deviation 0.258 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 3 | -0.13 Celsius | Standard Deviation 0.25 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 16 hour | 0.03 Celsius | Standard Deviation 0.225 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 4 | 0.02 Celsius | Standard Deviation 0.223 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 2 | -0.08 Celsius | Standard Deviation 0.117 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 12 hour | 0.23 Celsius | Standard Deviation 0.242 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 2 | 0.13 Celsius | Standard Deviation 0.186 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 6 hour | 0.93 Celsius | Standard Deviation 0.163 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 3 | -0.08 Celsius | Standard Deviation 0.204 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 2 hour | 0.87 Celsius | Standard Deviation 0.367 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 7 | 0.10 Celsius | Standard Deviation 0.228 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 4 | -0.12 Celsius | Standard Deviation 0.204 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 1 hour | 0.17 Celsius | Standard Deviation 0.327 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 8 hour | 0.75 Celsius | Standard Deviation 0.389 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 5 | 0.13 Celsius | Standard Deviation 0.234 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 16 hour | 0.32 Celsius | Standard Deviation 0.349 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 4 hour | 1.25 Celsius | Standard Deviation 0.295 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Body Temperature Part 1 | Day 1, 12 hour | 0.67 Celsius | Standard Deviation 0.294 |
Primary
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1
Systolic and diastolic BP was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Time frame: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.
Population: All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 16 hour | -3.2 Millimeter of mercury (mmHg) | Standard Deviation 6 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 2 hour | -4.3 Millimeter of mercury (mmHg) | Standard Deviation 4 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 4 hour | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 4.77 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 6 hour | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 4.86 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 8 hour | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 5.17 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 12 hour | -2.2 Millimeter of mercury (mmHg) | Standard Deviation 6.01 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 1 hour | -2.1 Millimeter of mercury (mmHg) | Standard Deviation 6.14 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 2 | 0.0 Millimeter of mercury (mmHg) | Standard Deviation 5.4 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 3 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 6.3 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 4 | 2.6 Millimeter of mercury (mmHg) | Standard Deviation 9.38 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 5 | 2.4 Millimeter of mercury (mmHg) | Standard Deviation 5.02 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 7 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 7.03 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 1 hour | 6.5 Millimeter of mercury (mmHg) | Standard Deviation 5.78 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 2 hour | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 6.53 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 4 hour | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 4.25 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 6 hour | 5.0 Millimeter of mercury (mmHg) | Standard Deviation 8.65 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 8 hour | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 8.04 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 12 hour | 3.9 Millimeter of mercury (mmHg) | Standard Deviation 11.56 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 16 hour | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 6.16 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 2 | -3.2 Millimeter of mercury (mmHg) | Standard Deviation 7.15 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 3 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 10.09 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 4 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 6.5 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 5 | 4.2 Millimeter of mercury (mmHg) | Standard Deviation 4.69 |
| Part 1: Placebo | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 7 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 6.81 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 8 hour | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 2.95 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 1 hour | 4.7 Millimeter of mercury (mmHg) | Standard Deviation 8.89 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 4 hour | -3.8 Millimeter of mercury (mmHg) | Standard Deviation 3.54 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 6 hour | 4.2 Millimeter of mercury (mmHg) | Standard Deviation 4.31 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 5 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 3.08 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 2 hour | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 5.56 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 4 hour | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 7.56 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 16 hour | -5.5 Millimeter of mercury (mmHg) | Standard Deviation 8.87 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 2 hour | -5.0 Millimeter of mercury (mmHg) | Standard Deviation 1.26 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 4 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 8.38 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 2 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 6.1 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 6 hour | -6.0 Millimeter of mercury (mmHg) | Standard Deviation 4.86 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 3 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 5.89 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 3 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 5.39 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 1 hour | -3.8 Millimeter of mercury (mmHg) | Standard Deviation 2.79 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 4 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 8.41 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 12 hour | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 6.25 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 2 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 3.6 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 7 | 5.3 Millimeter of mercury (mmHg) | Standard Deviation 8.91 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 5 | 4.2 Millimeter of mercury (mmHg) | Standard Deviation 4.54 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 16 hour | -6.8 Millimeter of mercury (mmHg) | Standard Deviation 6.43 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 12 hour | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 4.32 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 7 | 3.7 Millimeter of mercury (mmHg) | Standard Deviation 6.71 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 8 hour | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 5.68 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 4 | -8.2 Millimeter of mercury (mmHg) | Standard Deviation 19.86 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 8 hour | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 17.78 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 1 hour | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 9.05 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 3 | -5.0 Millimeter of mercury (mmHg) | Standard Deviation 8.99 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 4 hour | -3.7 Millimeter of mercury (mmHg) | Standard Deviation 5.05 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 4 hour | -4.2 Millimeter of mercury (mmHg) | Standard Deviation 11.99 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 5 | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 10.25 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 7 | -4.3 Millimeter of mercury (mmHg) | Standard Deviation 14.96 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 2 hour | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 11.23 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 3 | -7.8 Millimeter of mercury (mmHg) | Standard Deviation 15.94 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 2 | -5.0 Millimeter of mercury (mmHg) | Standard Deviation 17.44 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 5 | -2.5 Millimeter of mercury (mmHg) | Standard Deviation 17.76 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 6 hour | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 11.7 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 12 hour | -2.7 Millimeter of mercury (mmHg) | Standard Deviation 11.17 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 16 hour | -5.8 Millimeter of mercury (mmHg) | Standard Deviation 15.22 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 6 hour | -3.5 Millimeter of mercury (mmHg) | Standard Deviation 6.09 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 2 hour | -5.0 Millimeter of mercury (mmHg) | Standard Deviation 10.06 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 4 | -6.2 Millimeter of mercury (mmHg) | Standard Deviation 11.29 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 7 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 7.86 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 12 hour | 6.0 Millimeter of mercury (mmHg) | Standard Deviation 19.76 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 2 | -5.3 Millimeter of mercury (mmHg) | Standard Deviation 8.8 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 8 hour | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 5.47 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 16 hour | -7.2 Millimeter of mercury (mmHg) | Standard Deviation 22.51 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 1 hour | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 5.5 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 4 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 12.88 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 8 hour | -4.3 Millimeter of mercury (mmHg) | Standard Deviation 10.73 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 12 hour | -2.8 Millimeter of mercury (mmHg) | Standard Deviation 5.27 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 7 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 10.78 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 16 hour | -6.2 Millimeter of mercury (mmHg) | Standard Deviation 5.88 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 2 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 6.66 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 3 | 4.3 Millimeter of mercury (mmHg) | Standard Deviation 10.89 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 4 | -2.2 Millimeter of mercury (mmHg) | Standard Deviation 9.62 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 5 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 10.45 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 7 | 4.7 Millimeter of mercury (mmHg) | Standard Deviation 9.22 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 1 hour | 8.8 Millimeter of mercury (mmHg) | Standard Deviation 8.16 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 2 hour | -3.7 Millimeter of mercury (mmHg) | Standard Deviation 8.52 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 4 hour | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 6.35 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 5 | 9.5 Millimeter of mercury (mmHg) | Standard Deviation 13.43 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 6 hour | 1.8 Millimeter of mercury (mmHg) | Standard Deviation 10.46 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 8 hour | -2.7 Millimeter of mercury (mmHg) | Standard Deviation 10.98 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 12 hour | 6.2 Millimeter of mercury (mmHg) | Standard Deviation 5.85 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 16 hour | -6.8 Millimeter of mercury (mmHg) | Standard Deviation 8.11 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 2 | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 11.54 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 1 hour | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 4.27 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 2 hour | -6.5 Millimeter of mercury (mmHg) | Standard Deviation 2.43 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 4 hour | -3.7 Millimeter of mercury (mmHg) | Standard Deviation 5.82 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 3 | 5.0 Millimeter of mercury (mmHg) | Standard Deviation 8.39 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 6 hour | -5.3 Millimeter of mercury (mmHg) | Standard Deviation 8.21 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 5 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 2.07 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 3 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 6.51 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 4 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 5.85 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 4 hour | -4.5 Millimeter of mercury (mmHg) | Standard Deviation 4.14 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 1 hour | -3.2 Millimeter of mercury (mmHg) | Standard Deviation 5.23 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 16 hour | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 14.1 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 2 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 7.87 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 12 hour | 6.2 Millimeter of mercury (mmHg) | Standard Deviation 9.68 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 16 hour | -3.8 Millimeter of mercury (mmHg) | Standard Deviation 5.04 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 8 hour | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 5.23 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 2 hour | -4.8 Millimeter of mercury (mmHg) | Standard Deviation 3.43 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 7 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 6.31 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 4 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 4.1 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 2 hour | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 7.08 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 3 | 1.8 Millimeter of mercury (mmHg) | Standard Deviation 5.12 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 6 hour | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 6.34 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 4 hour | 1.7 Millimeter of mercury (mmHg) | Standard Deviation 8.55 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 2 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 5.16 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 12 hour | -4.3 Millimeter of mercury (mmHg) | Standard Deviation 7.03 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 1 hour | 3.3 Millimeter of mercury (mmHg) | Standard Deviation 6.12 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 7 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 11.5 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 8 hour | 2.5 Millimeter of mercury (mmHg) | Standard Deviation 6.25 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 6 hour | 7.5 Millimeter of mercury (mmHg) | Standard Deviation 9.35 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 5 | 5.0 Millimeter of mercury (mmHg) | Standard Deviation 4.65 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 6 hour | 3.2 Millimeter of mercury (mmHg) | Standard Deviation 6.46 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 7 | 3.2 Millimeter of mercury (mmHg) | Standard Deviation 9.43 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 6 hour | -7.5 Millimeter of mercury (mmHg) | Standard Deviation 6.38 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 8 hour | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 4.72 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 5 | 4.0 Millimeter of mercury (mmHg) | Standard Deviation 5.37 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 4 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 2.66 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 5 | 2.5 Millimeter of mercury (mmHg) | Standard Deviation 6.06 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 12 hour | 2.0 Millimeter of mercury (mmHg) | Standard Deviation 7.21 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 7 | 5.2 Millimeter of mercury (mmHg) | Standard Deviation 7.83 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 4 hour | -4.2 Millimeter of mercury (mmHg) | Standard Deviation 4.88 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 16 hour | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 13.29 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 4 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 6.23 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 2 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 6.85 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 3 | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 7.08 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 2 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 7 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 8 hour | -6.8 Millimeter of mercury (mmHg) | Standard Deviation 6.85 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 1 hour | -3.3 Millimeter of mercury (mmHg) | Standard Deviation 4.18 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 16 hour | -2.7 Millimeter of mercury (mmHg) | Standard Deviation 10.13 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 2 hour | -7.0 Millimeter of mercury (mmHg) | Standard Deviation 8.2 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 2 hour | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 6.05 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 1 hour | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 14.6 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | DBP, Day 1, 12 hour | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 8.32 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 1, 4 hour | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 3.37 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) Part 1 | SBP, Day 3 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 8.81 |
Primary
Change From Baseline in Pulse Rate Part 1
Pulse rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Time frame: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.
Population: All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 3 | 1.4 Beats per minute | Standard Deviation 3.27 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 2 | 0.3 Beats per minute | Standard Deviation 4.37 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 2 hour | 5.9 Beats per minute | Standard Deviation 5.36 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 7 | 7.4 Beats per minute | Standard Deviation 5.5 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 4 hour | 5.0 Beats per minute | Standard Deviation 7.67 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 5 | 7.3 Beats per minute | Standard Deviation 8.58 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 6 hour | 8.7 Beats per minute | Standard Deviation 6.73 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 1 hour | 8.1 Beats per minute | Standard Deviation 6.92 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 8 hour | 3.2 Beats per minute | Standard Deviation 6.49 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 4 | 3.2 Beats per minute | Standard Deviation 7.69 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 12 hour | 4.6 Beats per minute | Standard Deviation 8.45 |
| Part 1: Placebo | Change From Baseline in Pulse Rate Part 1 | Day 1, 16 hour | -1.9 Beats per minute | Standard Deviation 5.55 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 4 | 4.8 Beats per minute | Standard Deviation 7.6 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 16 hour | -2.0 Beats per minute | Standard Deviation 4.94 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 6 hour | 8.7 Beats per minute | Standard Deviation 3.98 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 7 | 7.0 Beats per minute | Standard Deviation 4.43 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 4 hour | 2.8 Beats per minute | Standard Deviation 2.99 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 2 | -0.3 Beats per minute | Standard Deviation 3.78 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 12 hour | 4.7 Beats per minute | Standard Deviation 5.99 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 8 hour | 1.7 Beats per minute | Standard Deviation 3.2 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 2 hour | 8.2 Beats per minute | Standard Deviation 8.57 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 3 | 5.5 Beats per minute | Standard Deviation 4.37 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 1 hour | 8.2 Beats per minute | Standard Deviation 3.31 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Pulse Rate Part 1 | Day 5 | 6.3 Beats per minute | Standard Deviation 6.41 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 8 hour | 4.7 Beats per minute | Standard Deviation 6.15 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 7 | 1.7 Beats per minute | Standard Deviation 10.46 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 4 hour | 11.7 Beats per minute | Standard Deviation 15.12 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 1 hour | 11.8 Beats per minute | Standard Deviation 7.65 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 12 hour | 5.2 Beats per minute | Standard Deviation 15.48 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 3 | -1.3 Beats per minute | Standard Deviation 12.71 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 6 hour | 10.8 Beats per minute | Standard Deviation 13.12 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 4 | -1.3 Beats per minute | Standard Deviation 13.84 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 16 hour | -0.8 Beats per minute | Standard Deviation 19.77 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 2 | 1.0 Beats per minute | Standard Deviation 7.64 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 2 hour | 11.3 Beats per minute | Standard Deviation 11.74 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Pulse Rate Part 1 | Day 5 | 2.2 Beats per minute | Standard Deviation 14.69 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 12 hour | 7.2 Beats per minute | Standard Deviation 4.07 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 1 hour | 16.7 Beats per minute | Standard Deviation 7.66 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 2 hour | 17.5 Beats per minute | Standard Deviation 8.6 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 4 hour | 17.8 Beats per minute | Standard Deviation 20.22 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 6 hour | 15.7 Beats per minute | Standard Deviation 17.07 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 8 hour | 4.7 Beats per minute | Standard Deviation 8.87 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 16 hour | -0.7 Beats per minute | Standard Deviation 5.61 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 2 | 4.3 Beats per minute | Standard Deviation 6.12 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 3 | 7.0 Beats per minute | Standard Deviation 7.62 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 4 | 4.5 Beats per minute | Standard Deviation 4.97 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 5 | 4.5 Beats per minute | Standard Deviation 5.24 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 7 | 3.8 Beats per minute | Standard Deviation 7.19 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 8 hour | 8.2 Beats per minute | Standard Deviation 5.74 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 4 hour | 17.3 Beats per minute | Standard Deviation 9.79 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 1 hour | 12.0 Beats per minute | Standard Deviation 5.1 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 7 | 6.7 Beats per minute | Standard Deviation 13.41 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 5 | 4.5 Beats per minute | Standard Deviation 7.56 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 6 hour | 17.7 Beats per minute | Standard Deviation 7.37 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 2 hour | 14.8 Beats per minute | Standard Deviation 9.45 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 3 | 2.0 Beats per minute | Standard Deviation 3.16 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 16 hour | 3.2 Beats per minute | Standard Deviation 2.64 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 4 | 2.2 Beats per minute | Standard Deviation 6.21 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 2 | 0.5 Beats per minute | Standard Deviation 4.04 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 12 hour | 10.5 Beats per minute | Standard Deviation 4.59 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 2 | 1.7 Beats per minute | Standard Deviation 8.16 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 8 hour | 6.3 Beats per minute | Standard Deviation 5.35 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 3 | -1.2 Beats per minute | Standard Deviation 5.71 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 6 hour | 15.7 Beats per minute | Standard Deviation 5.09 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 7 | 3.8 Beats per minute | Standard Deviation 5.19 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 4 | -2.3 Beats per minute | Standard Deviation 3.83 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 4 hour | 20.8 Beats per minute | Standard Deviation 5.42 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 2 hour | 14.3 Beats per minute | Standard Deviation 7.45 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 5 | 2.7 Beats per minute | Standard Deviation 3.01 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 16 hour | 2.8 Beats per minute | Standard Deviation 5.56 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 1 hour | 10.2 Beats per minute | Standard Deviation 4.88 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Pulse Rate Part 1 | Day 1, 12 hour | 9.0 Beats per minute | Standard Deviation 6.57 |
Primary
Change From Baseline in Respiratory Rate Part 1
Respiratory rate was measured in semi-supine position after 5 minutes rest. Baseline values are the last non-missing pre-dose assessments. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Time frame: Baseline, Day 1 (1, 2, 4, 6, 8, 12, 16 hours), Day 2, Day 3, Day 4, Day 5, and Day 7.
Population: All Subjects Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 12 hour | 0.4 Breaths per minute | Standard Deviation 2.37 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 4 hour | 0.2 Breaths per minute | Standard Deviation 1.14 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 7 | 0.3 Breaths per minute | Standard Deviation 1.89 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 1 hour | 0.2 Breaths per minute | Standard Deviation 1.03 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 8 hour | 1.3 Breaths per minute | Standard Deviation 2.31 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 2 | -0.3 Breaths per minute | Standard Deviation 1.7 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 4 | 0.6 Breaths per minute | Standard Deviation 2.01 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 6 hour | 0.9 Breaths per minute | Standard Deviation 2.96 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 3 | 0.4 Breaths per minute | Standard Deviation 1.9 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 5 | 0.4 Breaths per minute | Standard Deviation 0.97 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 2 hour | 0.3 Breaths per minute | Standard Deviation 1.49 |
| Part 1: Placebo | Change From Baseline in Respiratory Rate Part 1 | Day 1, 16 hour | -0.4 Breaths per minute | Standard Deviation 2.22 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 16 hour | -1.8 Breaths per minute | Standard Deviation 2.14 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 8 hour | 1.0 Breaths per minute | Standard Deviation 2.68 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 12 hour | -0.5 Breaths per minute | Standard Deviation 1.76 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 7 | -0.3 Breaths per minute | Standard Deviation 1.21 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 5 | -0.7 Breaths per minute | Standard Deviation 1.21 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 3 | -0.3 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 1 hour | 1.2 Breaths per minute | Standard Deviation 0.41 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 4 hour | 0.0 Breaths per minute | Standard Deviation 1.79 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 4 | -0.2 Breaths per minute | Standard Deviation 1.72 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 2 | 0.2 Breaths per minute | Standard Deviation 1.6 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 6 hour | 0.3 Breaths per minute | Standard Deviation 2.34 |
| Part 1: GSK1795091 7 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 2 hour | 0.2 Breaths per minute | Standard Deviation 0.75 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 2 | -0.3 Breaths per minute | Standard Deviation 0.82 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 5 | 0.5 Breaths per minute | Standard Deviation 3.27 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 7 | -0.5 Breaths per minute | Standard Deviation 1.87 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 4 hour | -0.2 Breaths per minute | Standard Deviation 2.93 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 1 hour | -0.2 Breaths per minute | Standard Deviation 1.17 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 6 hour | -0.7 Breaths per minute | Standard Deviation 1.51 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 8 hour | -0.3 Breaths per minute | Standard Deviation 1.97 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 12 hour | 0.0 Breaths per minute | Standard Deviation 3.22 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 16 hour | -1.3 Breaths per minute | Standard Deviation 2.25 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 3 | 0.3 Breaths per minute | Standard Deviation 3.56 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 4 | -0.5 Breaths per minute | Standard Deviation 2.26 |
| Part 1: GSK1795091 21 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 2 hour | -0.2 Breaths per minute | Standard Deviation 0.75 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 16 hour | 0.0 Breaths per minute | Standard Deviation 3.35 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 7 | 0.5 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 4 | -0.5 Breaths per minute | Standard Deviation 2.51 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 3 | 0.3 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 4 hour | 1.0 Breaths per minute | Standard Deviation 2 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 2 hour | 1.3 Breaths per minute | Standard Deviation 3.08 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 1 hour | 1.2 Breaths per minute | Standard Deviation 2.93 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 2 | -0.5 Breaths per minute | Standard Deviation 2.95 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 6 hour | -0.3 Breaths per minute | Standard Deviation 2.34 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 5 | 1.5 Breaths per minute | Standard Deviation 1.76 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 12 hour | 0.8 Breaths per minute | Standard Deviation 2.4 |
| Part 1: GSK1795091 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 8 hour | 0.8 Breaths per minute | Standard Deviation 4.36 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 12 hour | 0.8 Breaths per minute | Standard Deviation 1.72 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 6 hour | 1.5 Breaths per minute | Standard Deviation 2.74 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 4 | 0.5 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 16 hour | 0.7 Breaths per minute | Standard Deviation 1.75 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 4 hour | 1.2 Breaths per minute | Standard Deviation 2.04 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 2 hour | 1.0 Breaths per minute | Standard Deviation 0.89 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 2 | 1.5 Breaths per minute | Standard Deviation 2.17 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 7 | -0.3 Breaths per minute | Standard Deviation 1.86 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 3 | 1.3 Breaths per minute | Standard Deviation 2.34 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 5 | 0.8 Breaths per minute | Standard Deviation 1.47 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 1 hour | -0.2 Breaths per minute | Standard Deviation 1.6 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 8 hour | 0.8 Breaths per minute | Standard Deviation 1.72 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 7 | 0.5 Breaths per minute | Standard Deviation 2.07 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 1 hour | -0.2 Breaths per minute | Standard Deviation 1.94 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 2 hour | 0.2 Breaths per minute | Standard Deviation 1.94 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 4 hour | 1.5 Breaths per minute | Standard Deviation 4.04 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 6 hour | 0.7 Breaths per minute | Standard Deviation 3.27 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 8 hour | -0.5 Breaths per minute | Standard Deviation 2.88 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 12 hour | 0.5 Breaths per minute | Standard Deviation 3.56 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 1, 16 hour | -0.8 Breaths per minute | Standard Deviation 2.23 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 3 | -0.2 Breaths per minute | Standard Deviation 2.4 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 4 | -0.2 Breaths per minute | Standard Deviation 2.56 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 5 | 0.3 Breaths per minute | Standard Deviation 3.61 |
| Part 1: GSK1795091 100 ng | Change From Baseline in Respiratory Rate Part 1 | Day 2 | -0.3 Breaths per minute | Standard Deviation 3.01 |
Primary
Ketones and Urine Glucose at Indicated Time Points
Urinalysis included parameters like ketones and urine glucose. Data at indicated time points were reported.
Time frame: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 7 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 4 | 0.15 Millimoles per liter | Standard Deviation 0.242 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day 1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day -1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 2 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 2 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 7 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 4 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day 1 | 0.05 Millimoles per liter | Standard Deviation 0.158 |
| Part 1: Placebo | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day -1 | 0.05 Millimoles per liter | Standard Deviation 0.158 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day 1 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day -1 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 7 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 4 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 7 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 2 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day -1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 2 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day 1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 4 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 4 | 0.08 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 4 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 2 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day 1 | 0.25 Millimoles per liter | Standard Deviation 0.612 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 7 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 2 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 7 | 0.08 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day -1 | 0.08 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day -1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day 1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 4 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day 1 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day 1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day -1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day -1 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 4 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 7 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 7 | 0.25 Millimoles per liter | Standard Deviation 0.612 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 2 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 2 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 4 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day -1 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day 1 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 2 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 4 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 7 | 0.00 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day -1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day 1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 2 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 7 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day 1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Pre-dose Day -1 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 7 | 0.08 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 4 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 4 | 0.08 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Day 2 | 1.75 Millimoles per liter | Standard Deviation 2.525 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day 1 | 0.08 Millimoles per liter | Standard Deviation 0.204 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Ketones, Pre-dose Day -1 | 0.25 Millimoles per liter | Standard Deviation 0.612 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 7 | 0.0 Millimoles per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Ketones and Urine Glucose at Indicated Time Points | Urine glucose, Day 2 | 0.0 Millimoles per liter | Standard Deviation 0 |
Primary
Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline
Single measurements of 12-lead ECGs were obtained after 10 minutes of rest in a semi-supine position for the participant. Participants with abnormal ECG findings that are clinically not significant (NCS) and clinically significant (CS) data has been presented here. The data of worst case post-Baseline is presented here.
Time frame: Up to Day 32
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | NCS | 3 Participants |
| Part 1: Placebo | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | CS | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | NCS | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | CS | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | NCS | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | CS | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | NCS | 2 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | CS | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | NCS | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | CS | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | NCS | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Abnormal Electrocardiograms (ECG) Findings Worst Case Post-Baseline | CS | 0 Participants |
Primary
Number of Participants With Clinical Chemistry Parameters Outside Reference Range
Clinical chemistry parameters with reference range were albumin 35-52\*g/L, Alkaline phosphatase (ALP) 30-120\*International units/L (IU/L), Alanine aminotransferase (ALT) 0-50 \* IU/L, Aspartate aminotransferase (AST) 0-50\*IU/L, direct bilirubin 0-3.4\* micromoles/L (µmol/L), bilirubin 5-21\*µmol/L, calcium 2.2-2.65\* millimoles/L (mmol/L), cholesterol 0-5.19\* mmol/L, creatinine 59-104\* µmol/L, C-reactive protein (CRP) 0-5\*milligram (mg)/L,Gamma Glutamyl Transferase (GGT) 4.1-5.9\*mmol/L, high density lipoproteins (HDL) cholesterol 0.99-2.32\*mmol/L, potassium 3.5-5.1\*mmol/L, low density lipoproteins (LDL) cholesterol 0-3.3\*mmol/L, protein 66-83\*g/L, sodium 136-146 \* mmol/L, triglycerides 0-2.25 \* mmol/L, glucose 4.1-5.9\*mmol/L, and urea 2.8-7.2\*mmol/L. Values below these ranges were considered as low and above these ranges were considered as high. Data for participants from any visit post-screening with values \> reference range high and \< reference range low are reported.
Time frame: Up to Day 7
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP,< reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin,> reference range H | 1 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, > reference range H | 1 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin,> reference range H | 1 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium, < reference range low | 2 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, < reference range low | 3 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, > reference range H | 00 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, > reference range H | 2 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein, < reference range low | 4 Participants |
| Part 1: Placebo | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP,< reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein, < reference range low | 4 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin,> reference range H | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium, < reference range low | 2 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea,> reference range H | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea, < reference range low | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, > reference range H | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein, < reference range low | 3 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium, < reference range low | 3 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, > reference range H | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, > reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP, > reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP,< reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, > reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, > reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, > reference range H | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine,> reference range H | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose,> reference range H | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, < reference range low | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, < reference range low | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium, < reference range low | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP,< reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium, < reference range low | 2 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, > reference range H | 4 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose, < reference range low | 2 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, > reference range H | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein, < reference range low | 4 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea, < reference range low | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP,< reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, > reference range H | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, > reference range H | 5 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium, < reference range low | 2 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium, < reference range low | 3 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein, < reference range low | 4 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein, < reference range low | 5 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose, < reference range low | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Indirect bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Glucose,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Protein,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | CRP, > reference range H | 6 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALT, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Albumin, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium, < reference range low | 3 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Creatinine, < reference range low | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Sodium,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Bilirubin, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium, < reference range low | 2 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | AST, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Direct Bilirubin,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Urea,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | ALP,< reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Potassium,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Clinical Chemistry Parameters Outside Reference Range | Calcium,> reference range H | 0 Participants |
Primary
Number of Participants With Hematology Parameters Outside Reference Range Part 1
Hematology parameters included hemoglobin (HGB), hematocrit (HCT), Red Blood Cell (RBC) count, White Blood Cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC). Reference range for basophil was 0.01 - 0.07\*10\^9/Liters (L), eosinophils 0.03 - 0.5\*10\^9/L, HCT 0.38 - 0.48 proportion of RBC in blood, HGB 126 - 165\*gram (g)/L, lymphocytes 1.08 - 3\*10\^9/L, MCH 26.3 - 32.8\*picogram (pg), MCHC 324 - 359\*g/L, MCV 77 - 94.9\*femtoliter (fL), monocytes 0.3 - 0.92\*10\^9/L, neutrophils 1.46 - 5.85\*10\^9/L, platelets 155 - 342\*10\^9/L, erythrocytes 4.12 - 5.74\*10\^12/L, leukocytes 3.19 - 8.71\*10\^9/L. Values below these ranges were considered as low and above these ranges were considered as high (H). Data for participants from any visit post-screening with values \> reference range high and \< reference range low are report.
Time frame: Up to Day 7
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, > reference range H | 2 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC,< reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes, < reference range low | 4 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes,> reference range H | 3 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes,> reference range H | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB, < reference range low | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB,> reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, < reference range low | 2 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT,> reference range H | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, < reference range low | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, > reference range H | 0 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC, > reference range H | 1 Participants |
| Part 1: Placebo | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils, < reference range low | 2 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC,< reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, > reference range H | 2 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, > reference range H | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, > reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, < reference range low | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT, < reference range low | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes,> reference range H | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes,> reference range H | 1 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes, < reference range low | 3 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes, < reference range low | 4 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils, < reference range low | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets,> reference range H | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets, < reference range low | 3 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC,< reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, > reference range H | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes,> reference range H | 5 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, > reference range H | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, > reference range H | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils,> reference range H | 5 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes, < reference range low | 5 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC, > reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, < reference range low | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes,> reference range H | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, < reference range low | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, > reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT,> reference range H | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, > reference range H | 1 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes, < reference range low | 3 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils, < reference range low | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT, < reference range low | 1 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes,> reference range H | 4 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes, < reference range low | 2 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes, < reference range low | 6 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes, < reference range low | 6 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils,> reference range H | 4 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC,< reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, > reference range H | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, < reference range low | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes, < reference range low | 6 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, < reference range low | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes, < reference range low | 6 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC,< reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB,> reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils,> reference range H | 5 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, > reference range H | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes,> reference range H | 5 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT, < reference range low | 1 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, > reference range H | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, > reference range H | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, > reference range H | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes, < reference range low | 6 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes, < reference range low | 3 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Basophil, > reference range H | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HCT, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCH, < reference range low | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Eosinophils, < reference range low | 2 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils,> reference range H | 6 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Leukocytes,> reference range H | 5 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Lymphocytes, < reference range low | 6 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC,< reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Erythrocytes, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCHC, > reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Monocytes,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | HGB,> reference range H | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Platelets, < reference range low | 1 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | MCV, < reference range low | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Hematology Parameters Outside Reference Range Part 1 | Neutrophils, < reference range low | 3 Participants |
Primary
Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or events associated with liver injury and impaired liver function were categorized as SAE. All participants enrolled into the study who have received a dose of study medication (GSK1795091 or placebo) were included in the All Subjects Population. Participants with non-serious AEs (5 percentage threshold) and SAEs has been reported.
Time frame: Up to Day 32
Population: All Subjects Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Part 1: Placebo | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-SAE (>= 5%) | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Part 1: GSK1795091 7 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-SAE (>= 5%) | 2 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Part 1: GSK1795091 21 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-SAE (>= 5%) | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Part 1: GSK1795091 60 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-SAE (>= 5%) | 5 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Part 1: GSK1795091 Repeated 60 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-SAE (>= 5%) | 3 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Any SAE | 0 Participants |
| Part 1: GSK1795091 100 ng | Number of Participants With Non-serious Adverse Events (AE) and Serious Adverse Events (SAE) | Non-SAE (>= 5%) | 5 Participants |
Primary
Occult Blood at Indicated Time Points
Urinalysis included parameter like Occult blood. Data at indicated time points were reported.
Time frame: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Occult Blood at Indicated Time Points | Day 4 | 4.5 10^9 cells per liter | Standard Deviation 8.32 |
| Part 1: Placebo | Occult Blood at Indicated Time Points | Pre-dose Day 1 | 4.5 10^9 cells per liter | Standard Deviation 8.32 |
| Part 1: Placebo | Occult Blood at Indicated Time Points | Pre-dose Day -1 | 2.5 10^9 cells per liter | Standard Deviation 7.91 |
| Part 1: Placebo | Occult Blood at Indicated Time Points | Day 7 | 4.0 10^9 cells per liter | Standard Deviation 5.16 |
| Part 1: Placebo | Occult Blood at Indicated Time Points | Day 2 | 2.5 10^9 cells per liter | Standard Deviation 7.91 |
| Part 1: GSK1795091 7 ng | Occult Blood at Indicated Time Points | Pre-dose Day 1 | 1.7 10^9 cells per liter | Standard Deviation 4.08 |
| Part 1: GSK1795091 7 ng | Occult Blood at Indicated Time Points | Day 4 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Occult Blood at Indicated Time Points | Pre-dose Day -1 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Occult Blood at Indicated Time Points | Day 7 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Occult Blood at Indicated Time Points | Day 2 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Occult Blood at Indicated Time Points | Pre-dose Day 1 | 3.3 10^9 cells per liter | Standard Deviation 5.16 |
| Part 1: GSK1795091 21 ng | Occult Blood at Indicated Time Points | Day 4 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Occult Blood at Indicated Time Points | Day 7 | 8.3 10^9 cells per liter | Standard Deviation 12.91 |
| Part 1: GSK1795091 21 ng | Occult Blood at Indicated Time Points | Day 2 | 5.0 10^9 cells per liter | Standard Deviation 5.48 |
| Part 1: GSK1795091 21 ng | Occult Blood at Indicated Time Points | Pre-dose Day -1 | 5.8 10^9 cells per liter | Standard Deviation 10.21 |
| Part 1: GSK1795091 60 ng | Occult Blood at Indicated Time Points | Day 2 | 4.2 10^9 cells per liter | Standard Deviation 10.21 |
| Part 1: GSK1795091 60 ng | Occult Blood at Indicated Time Points | Pre-dose Day -1 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Occult Blood at Indicated Time Points | Pre-dose Day 1 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Occult Blood at Indicated Time Points | Day 4 | 4.2 10^9 cells per liter | Standard Deviation 10.21 |
| Part 1: GSK1795091 60 ng | Occult Blood at Indicated Time Points | Day 7 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Occult Blood at Indicated Time Points | Day 4 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Occult Blood at Indicated Time Points | Pre-dose Day -1 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Occult Blood at Indicated Time Points | Day 7 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Occult Blood at Indicated Time Points | Pre-dose Day 1 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Occult Blood at Indicated Time Points | Day 2 | 1.7 10^9 cells per liter | Standard Deviation 4.08 |
| Part 1: GSK1795091 100 ng | Occult Blood at Indicated Time Points | Pre-dose Day -1 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Occult Blood at Indicated Time Points | Day 4 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Occult Blood at Indicated Time Points | Pre-dose Day 1 | 1.7 10^9 cells per liter | Standard Deviation 4.08 |
| Part 1: GSK1795091 100 ng | Occult Blood at Indicated Time Points | Day 7 | 0.0 10^9 cells per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Occult Blood at Indicated Time Points | Day 2 | 5.8 10^9 cells per liter | Standard Deviation 10.21 |
Primary
Specific Gravity at Indicated Time Points
Urinalysis included parameter like specific gravity. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine.
Time frame: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Specific Gravity at Indicated Time Points | Day 4 | 1.019 Ratio | Standard Deviation 0.0069 |
| Part 1: Placebo | Specific Gravity at Indicated Time Points | Pre-dose Day 1 | 1.014 Ratio | Standard Deviation 0.0072 |
| Part 1: Placebo | Specific Gravity at Indicated Time Points | Pre-dose Day -1 | 1.018 Ratio | Standard Deviation 0.0065 |
| Part 1: Placebo | Specific Gravity at Indicated Time Points | Day 7 | 1.016 Ratio | Standard Deviation 0.0082 |
| Part 1: Placebo | Specific Gravity at Indicated Time Points | Day 2 | 1.017 Ratio | Standard Deviation 0.0049 |
| Part 1: GSK1795091 7 ng | Specific Gravity at Indicated Time Points | Pre-dose Day 1 | 1.011 Ratio | Standard Deviation 0.0048 |
| Part 1: GSK1795091 7 ng | Specific Gravity at Indicated Time Points | Day 4 | 1.014 Ratio | Standard Deviation 0.0041 |
| Part 1: GSK1795091 7 ng | Specific Gravity at Indicated Time Points | Pre-dose Day -1 | 1.008 Ratio | Standard Deviation 0.0053 |
| Part 1: GSK1795091 7 ng | Specific Gravity at Indicated Time Points | Day 7 | 1.006 Ratio | Standard Deviation 0.0025 |
| Part 1: GSK1795091 7 ng | Specific Gravity at Indicated Time Points | Day 2 | 1.013 Ratio | Standard Deviation 0.0055 |
| Part 1: GSK1795091 21 ng | Specific Gravity at Indicated Time Points | Pre-dose Day 1 | 1.015 Ratio | Standard Deviation 0.0083 |
| Part 1: GSK1795091 21 ng | Specific Gravity at Indicated Time Points | Day 4 | 1.018 Ratio | Standard Deviation 0.0072 |
| Part 1: GSK1795091 21 ng | Specific Gravity at Indicated Time Points | Day 7 | 1.015 Ratio | Standard Deviation 0.0117 |
| Part 1: GSK1795091 21 ng | Specific Gravity at Indicated Time Points | Day 2 | 1.017 Ratio | Standard Deviation 0.0041 |
| Part 1: GSK1795091 21 ng | Specific Gravity at Indicated Time Points | Pre-dose Day -1 | 1.017 Ratio | Standard Deviation 0.0091 |
| Part 1: GSK1795091 60 ng | Specific Gravity at Indicated Time Points | Day 2 | 1.016 Ratio | Standard Deviation 0.0044 |
| Part 1: GSK1795091 60 ng | Specific Gravity at Indicated Time Points | Pre-dose Day -1 | 1.015 Ratio | Standard Deviation 0.0019 |
| Part 1: GSK1795091 60 ng | Specific Gravity at Indicated Time Points | Pre-dose Day 1 | 1.013 Ratio | Standard Deviation 0.0063 |
| Part 1: GSK1795091 60 ng | Specific Gravity at Indicated Time Points | Day 4 | 1.016 Ratio | Standard Deviation 0.0038 |
| Part 1: GSK1795091 60 ng | Specific Gravity at Indicated Time Points | Day 7 | 1.015 Ratio | Standard Deviation 0.009 |
| Part 1: GSK1795091 Repeated 60 ng | Specific Gravity at Indicated Time Points | Day 4 | 1.014 Ratio | Standard Deviation 0.0061 |
| Part 1: GSK1795091 Repeated 60 ng | Specific Gravity at Indicated Time Points | Pre-dose Day -1 | 1.008 Ratio | Standard Deviation 0.003 |
| Part 1: GSK1795091 Repeated 60 ng | Specific Gravity at Indicated Time Points | Day 7 | 1.010 Ratio | Standard Deviation 0.0079 |
| Part 1: GSK1795091 Repeated 60 ng | Specific Gravity at Indicated Time Points | Pre-dose Day 1 | 1.008 Ratio | Standard Deviation 0.0031 |
| Part 1: GSK1795091 Repeated 60 ng | Specific Gravity at Indicated Time Points | Day 2 | 1.014 Ratio | Standard Deviation 0.0048 |
| Part 1: GSK1795091 100 ng | Specific Gravity at Indicated Time Points | Pre-dose Day -1 | 1.019 Ratio | Standard Deviation 0.0047 |
| Part 1: GSK1795091 100 ng | Specific Gravity at Indicated Time Points | Day 4 | 1.016 Ratio | Standard Deviation 0.0059 |
| Part 1: GSK1795091 100 ng | Specific Gravity at Indicated Time Points | Pre-dose Day 1 | 1.014 Ratio | Standard Deviation 0.006 |
| Part 1: GSK1795091 100 ng | Specific Gravity at Indicated Time Points | Day 7 | 1.013 Ratio | Standard Deviation 0.0058 |
| Part 1: GSK1795091 100 ng | Specific Gravity at Indicated Time Points | Day 2 | 1.017 Ratio | Standard Deviation 0.0072 |
Primary
Urine Potential of Hydrogen (pH) at Indicated Time Points
Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0).
Time frame: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7
Population: All Subject Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 4 | 5.95 pH | Standard Deviation 0.725 |
| Part 1: Placebo | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day 1 | 6.05 pH | Standard Deviation 0.926 |
| Part 1: Placebo | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 | 6.10 pH | Standard Deviation 0.843 |
| Part 1: Placebo | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 7 | 6.00 pH | Standard Deviation 0.882 |
| Part 1: Placebo | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 2 | 6.20 pH | Standard Deviation 0.753 |
| Part 1: GSK1795091 7 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day 1 | 5.83 pH | Standard Deviation 0.931 |
| Part 1: GSK1795091 7 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 4 | 5.67 pH | Standard Deviation 1.033 |
| Part 1: GSK1795091 7 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 | 6.42 pH | Standard Deviation 0.801 |
| Part 1: GSK1795091 7 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 7 | 5.58 pH | Standard Deviation 0.917 |
| Part 1: GSK1795091 7 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 2 | 5.83 pH | Standard Deviation 0.983 |
| Part 1: GSK1795091 21 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day 1 | 5.75 pH | Standard Deviation 0.822 |
| Part 1: GSK1795091 21 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 4 | 5.50 pH | Standard Deviation 0.775 |
| Part 1: GSK1795091 21 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 7 | 5.25 pH | Standard Deviation 0.612 |
| Part 1: GSK1795091 21 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 2 | 5.92 pH | Standard Deviation 0.801 |
| Part 1: GSK1795091 21 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 | 5.00 pH | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 2 | 6.25 pH | Standard Deviation 0.689 |
| Part 1: GSK1795091 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 | 5.83 pH | Standard Deviation 0.931 |
| Part 1: GSK1795091 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day 1 | 5.50 pH | Standard Deviation 0.837 |
| Part 1: GSK1795091 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 4 | 5.92 pH | Standard Deviation 1.021 |
| Part 1: GSK1795091 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 7 | 5.75 pH | Standard Deviation 0.88 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 4 | 6.08 pH | Standard Deviation 0.917 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 | 6.50 pH | Standard Deviation 0.775 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 7 | 5.92 pH | Standard Deviation 0.801 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day 1 | 6.25 pH | Standard Deviation 0.758 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 2 | 5.33 pH | Standard Deviation 0.516 |
| Part 1: GSK1795091 100 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day -1 | 5.67 pH | Standard Deviation 0.753 |
| Part 1: GSK1795091 100 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 4 | 5.67 pH | Standard Deviation 0.816 |
| Part 1: GSK1795091 100 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Pre-dose Day 1 | 5.33 pH | Standard Deviation 0.816 |
| Part 1: GSK1795091 100 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 7 | 6.08 pH | Standard Deviation 0.917 |
| Part 1: GSK1795091 100 ng | Urine Potential of Hydrogen (pH) at Indicated Time Points | Day 2 | 5.50 pH | Standard Deviation 0.837 |
Primary
Urine Protein at Indicated Time Points
Urinalysis included parameter like Urine protein. Data at indicated time points were reported.
Time frame: Pre-dose Day -1 and Day 1, Day 2, Day 4 and Day 7
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Urine Protein at Indicated Time Points | Day 4 | 0.025 Gram per liter | Standard Deviation 0.0791 |
| Part 1: Placebo | Urine Protein at Indicated Time Points | Pre-dose Day 1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: Placebo | Urine Protein at Indicated Time Points | Pre-dose Day -1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: Placebo | Urine Protein at Indicated Time Points | Day 7 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: Placebo | Urine Protein at Indicated Time Points | Day 2 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Urine Protein at Indicated Time Points | Pre-dose Day 1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Urine Protein at Indicated Time Points | Day 4 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Urine Protein at Indicated Time Points | Pre-dose Day -1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Urine Protein at Indicated Time Points | Day 7 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 7 ng | Urine Protein at Indicated Time Points | Day 2 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Urine Protein at Indicated Time Points | Pre-dose Day 1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Urine Protein at Indicated Time Points | Day 4 | 0.042 Gram per liter | Standard Deviation 0.1021 |
| Part 1: GSK1795091 21 ng | Urine Protein at Indicated Time Points | Day 7 | 0.042 Gram per liter | Standard Deviation 0.1021 |
| Part 1: GSK1795091 21 ng | Urine Protein at Indicated Time Points | Day 2 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 21 ng | Urine Protein at Indicated Time Points | Pre-dose Day -1 | 0.042 Gram per liter | Standard Deviation 0.1021 |
| Part 1: GSK1795091 60 ng | Urine Protein at Indicated Time Points | Day 2 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Urine Protein at Indicated Time Points | Pre-dose Day -1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Urine Protein at Indicated Time Points | Pre-dose Day 1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Urine Protein at Indicated Time Points | Day 4 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 60 ng | Urine Protein at Indicated Time Points | Day 7 | 0.042 Gram per liter | Standard Deviation 0.1021 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Protein at Indicated Time Points | Day 4 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Protein at Indicated Time Points | Pre-dose Day -1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Protein at Indicated Time Points | Day 7 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Protein at Indicated Time Points | Pre-dose Day 1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 Repeated 60 ng | Urine Protein at Indicated Time Points | Day 2 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Urine Protein at Indicated Time Points | Pre-dose Day -1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Urine Protein at Indicated Time Points | Day 4 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Urine Protein at Indicated Time Points | Pre-dose Day 1 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Urine Protein at Indicated Time Points | Day 7 | 0.000 Gram per liter | Standard Deviation 0 |
| Part 1: GSK1795091 100 ng | Urine Protein at Indicated Time Points | Day 2 | 0.000 Gram per liter | Standard Deviation 0 |
Secondary
Accumulation Ratio of GSK1795091 for Part 2
Accumulation ratio assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data were not collected for part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Area Under the Concentration-time Curve (AUC) Time Curve for a Dosing Interval (AUC[0-tau]), AUC (0-last) of GSK1795091 for Part 2
AUC (0-tau) and AUC (0-last) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Change From Baseline in Body Temperature for Part 2
Body temperature was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline and up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Change From Baseline in CRP for Part 1
Blood samples were collected at indicated time points for the assessment of CRP. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value.
Time frame: Baseline, Days 2, 4 and 7
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in CRP for Part 1 | Day 4 | -0.101 mg/L | Standard Deviation 0.3839 |
| Part 1: Placebo | Change From Baseline in CRP for Part 1 | Day 2 | -0.074 mg/L | Standard Deviation 0.1852 |
| Part 1: Placebo | Change From Baseline in CRP for Part 1 | Day 7 | 0.468 mg/L | Standard Deviation 1.313 |
| Part 1: GSK1795091 7 ng | Change From Baseline in CRP for Part 1 | Day 4 | 0.098 mg/L | Standard Deviation 0.148 |
| Part 1: GSK1795091 7 ng | Change From Baseline in CRP for Part 1 | Day 2 | 0.448 mg/L | Standard Deviation 0.7342 |
| Part 1: GSK1795091 7 ng | Change From Baseline in CRP for Part 1 | Day 7 | 0.338 mg/L | Standard Deviation 0.3712 |
| Part 1: GSK1795091 21 ng | Change From Baseline in CRP for Part 1 | Day 4 | 0.748 mg/L | Standard Deviation 0.5974 |
| Part 1: GSK1795091 21 ng | Change From Baseline in CRP for Part 1 | Day 2 | 4.550 mg/L | Standard Deviation 3.8044 |
| Part 1: GSK1795091 21 ng | Change From Baseline in CRP for Part 1 | Day 7 | 0.128 mg/L | Standard Deviation 0.3022 |
| Part 1: GSK1795091 60 ng | Change From Baseline in CRP for Part 1 | Day 4 | 2.430 mg/L | Standard Deviation 2.3835 |
| Part 1: GSK1795091 60 ng | Change From Baseline in CRP for Part 1 | Day 2 | 10.413 mg/L | Standard Deviation 10.7622 |
| Part 1: GSK1795091 60 ng | Change From Baseline in CRP for Part 1 | Day 7 | 4.802 mg/L | Standard Deviation 9.2888 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in CRP for Part 1 | Day 4 | 2.362 mg/L | Standard Deviation 1.4852 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in CRP for Part 1 | Day 2 | 11.900 mg/L | Standard Deviation 6.1323 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in CRP for Part 1 | Day 7 | 1.305 mg/L | Standard Deviation 0.8481 |
| Part 1: GSK1795091 100 ng | Change From Baseline in CRP for Part 1 | Day 2 | 19.442 mg/L | Standard Deviation 1.9676 |
| Part 1: GSK1795091 100 ng | Change From Baseline in CRP for Part 1 | Day 7 | 1.428 mg/L | Standard Deviation 1.04 |
| Part 1: GSK1795091 100 ng | Change From Baseline in CRP for Part 1 | Day 4 | 3.760 mg/L | Standard Deviation 1.2465 |
Secondary
Change From Baseline in CRP for Part 2
CRP assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline and Pre-dose, 1, 2, 4, 8, 12, 16, 24, and 48 hours post dose
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Change From Baseline in Pulse Rate for Part 2
Pulse rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline and up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Change From Baseline in Respiratory Rate for Part 2
Respiratory rate was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline and up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Change From Baseline in SBP and DBP for Part 2
SBP and DBP was planned to be measured in Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline and up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Change From Baseline in WBC Differential for Part 1
WBC differential included Lymphocytes Count, Monocytes Count, Granulocytes Count including neutrophils and eosinophil. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Time frame: Baseline, 4, 24 and 144 hours
Population: All Subjects Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.135 10^9 cells per liter | Standard Deviation 0.2034 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.080 10^9 cells per liter | Standard Deviation 0.395 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | 0.002 10^9 cells per liter | Standard Deviation 0.0959 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.067 10^9 cells per liter | Standard Deviation 0.935 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.082 10^9 cells per liter | Standard Deviation 0.2017 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.400 10^9 cells per liter | Standard Deviation 0.5482 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.072 10^9 cells per liter | Standard Deviation 0.1631 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.012 10^9 cells per liter | Standard Deviation 0.0543 |
| Part 1: Placebo | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.076 10^9 cells per liter | Standard Deviation 0.2703 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.107 10^9 cells per liter | Standard Deviation 0.1786 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6 | 0.292 10^9 cells per liter | Standard Deviation 0.6764 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.038 10^9 cells per liter | Standard Deviation 0.1411 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | 0.013 10^9 cells per liter | Standard Deviation 0.1454 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.156 10^9 cells per liter | Standard Deviation 0.1228 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.045 10^9 cells per liter | Standard Deviation 0.2957 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6 | 1.548 10^9 cells per liter | Standard Deviation 0.8217 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | -0.118 10^9 cells per liter | Standard Deviation 0.307 |
| Part 1: GSK1795091 7 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.062 10^9 cells per liter | Standard Deviation 0.7474 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.018 10^9 cells per liter | Standard Deviation 0.0807 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.669 10^9 cells per liter | Standard Deviation 1.1381 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6 | 3.708 10^9 cells per liter | Standard Deviation 0.8286 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.051 10^9 cells per liter | Standard Deviation 0.2327 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.030 10^9 cells per liter | Standard Deviation 0.249 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.054 10^9 cells per liter | Standard Deviation 0.0746 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | -0.603 10^9 cells per liter | Standard Deviation 0.2988 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.691 10^9 cells per liter | Standard Deviation 0.8687 |
| Part 1: GSK1795091 21 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.253 10^9 cells per liter | Standard Deviation 0.0759 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6 | 0.245 10^9 cells per liter | Standard Deviation 0.9796 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.129 10^9 cells per liter | Standard Deviation 0.2242 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.035 10^9 cells per liter | Standard Deviation 0.1415 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | 0.040 10^9 cells per liter | Standard Deviation 0.1065 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6 | 3.747 10^9 cells per liter | Standard Deviation 2.3033 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.122 10^9 cells per liter | Standard Deviation 0.6265 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | -0.393 10^9 cells per liter | Standard Deviation 0.7111 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.042 10^9 cells per liter | Standard Deviation 0.5468 |
| Part 1: GSK1795091 60 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | 0.060 10^9 cells per liter | Standard Deviation 0.6556 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.176 10^9 cells per liter | Standard Deviation 0.3004 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6 | 3.856 10^9 cells per liter | Standard Deviation 0.8005 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | -0.997 10^9 cells per liter | Standard Deviation 0.4404 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.012 10^9 cells per liter | Standard Deviation 0.0861 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.175 10^9 cells per liter | Standard Deviation 0.5181 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.247 10^9 cells per liter | Standard Deviation 0.2634 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.004 10^9 cells per liter | Standard Deviation 0.08 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | 0.169 10^9 cells per liter | Standard Deviation 0.1512 |
| Part 1: GSK1795091 Repeated 60 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.073 10^9 cells per liter | Standard Deviation 1.0629 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | -0.061 10^9 cells per liter | Standard Deviation 0.1629 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 4 hour, n=10, 6, 6, 5, 6, 6 | 4.018 10^9 cells per liter | Standard Deviation 4.936 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.974 10^9 cells per liter | Standard Deviation 1.9877 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.266 10^9 cells per liter | Standard Deviation 0.6911 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.489 10^9 cells per liter | Standard Deviation 0.7405 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Lymphocytes count, 4 hour, n=10, 6, 6, 5, 6, 6 | -1.419 10^9 cells per liter | Standard Deviation 1.3685 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 144 hour, n=10, 6, 6, 6, 6, 6 | -0.038 10^9 cells per liter | Standard Deviation 0.0321 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Granulocytes Count, 24 hour, n=10, 6, 6, 6, 4, 6 | -0.940 10^9 cells per liter | Standard Deviation 2.3939 |
| Part 1: GSK1795091 100 ng | Change From Baseline in WBC Differential for Part 1 | Monocytes count, 24 hour, n=10, 6, 6, 6, 4, 6 | 0.104 10^9 cells per liter | Standard Deviation 0.3037 |
Secondary
Change From Baseline in WBC Differential for Part 2
WBC differential assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 2, 24 and 144 hours
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Clearance (CL) of GSK1795091 for Part 1
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo | Clearance (CL) of GSK1795091 for Part 1 | NA Liters per hour (L/h) | — |
| Part 1: GSK1795091 7 ng | Clearance (CL) of GSK1795091 for Part 1 | 0.202 Liters per hour (L/h) | Geometric Coefficient of Variation 52.2 |
| Part 1: GSK1795091 21 ng | Clearance (CL) of GSK1795091 for Part 1 | 0.144 Liters per hour (L/h) | Geometric Coefficient of Variation 40 |
| Part 1: GSK1795091 60 ng | Clearance (CL) of GSK1795091 for Part 1 | 0.113 Liters per hour (L/h) | Geometric Coefficient of Variation 26.3 |
| Part 1: GSK1795091 Repeated 60 ng | Clearance (CL) of GSK1795091 for Part 1 | 0.0693 Liters per hour (L/h) | Geometric Coefficient of Variation 15.9 |
Secondary
Clearance (CL) of GSK1795091 for Part 2
CL assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1
Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated for each participant using a non-compartmental method. All participants for whom, at least, one valid and evaluable pharmacokinetic parameter (AUC or Cmax) was derived were included in PK Parameter Population. Only those participants with data available at the specified data points were analyzed.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | NA Picogram/milliliter (pg/mL) | — |
| Part 1: GSK1795091 7 ng | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | 3.78 Picogram/milliliter (pg/mL) | Geometric Coefficient of Variation 15.9 |
| Part 1: GSK1795091 21 ng | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | 10.1 Picogram/milliliter (pg/mL) | Geometric Coefficient of Variation 13 |
| Part 1: GSK1795091 60 ng | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | 9.45 Picogram/milliliter (pg/mL) | Geometric Coefficient of Variation 25.5 |
| Part 1: GSK1795091 Repeated 60 ng | Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 1 | 23.7 Picogram/milliliter (pg/mL) | Geometric Coefficient of Variation 6.69 |
Secondary
Maximum Observed Drug Concentration (Cmax) of GSK1795091 for Part 2
Cmax assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of Adverse events (AEs) of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Number of Participants With Clinical Chemistry Parameters Outside Reference Range in Part 2
Clinical chemistry as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Number of Participants With Hematology Parameters Outside Reference Range in Part 2
Hematology as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Number of Participants With Urinalysis Parameters Outside Reference Range for Part 2
Urinalysis as part of safety assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Up to Day 7
Population: All Subjects Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. AUC (0-t) was used interchangeably with AUC to last time of quantifiable concentration (AUC\[0-last\]) .Only those participants with data available at the specified data points were analyzed.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-t) | NA Hours*pg/mL | — |
| Part 1: Placebo | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-inf) | NA Hours*pg/mL | — |
| Part 1: GSK1795091 7 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-t) | 21.1 Hours*pg/mL | Geometric Coefficient of Variation 89.7 |
| Part 1: GSK1795091 7 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-inf) | 104 Hours*pg/mL | Geometric Coefficient of Variation 52.2 |
| Part 1: GSK1795091 21 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-t) | 233 Hours*pg/mL | Geometric Coefficient of Variation 56.4 |
| Part 1: GSK1795091 21 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-inf) | 417 Hours*pg/mL | Geometric Coefficient of Variation 40 |
| Part 1: GSK1795091 60 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-inf) | 532 Hours*pg/mL | Geometric Coefficient of Variation 26.3 |
| Part 1: GSK1795091 60 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-t) | 264 Hours*pg/mL | Geometric Coefficient of Variation 33.3 |
| Part 1: GSK1795091 Repeated 60 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-t) | 1100 Hours*pg/mL | Geometric Coefficient of Variation 12.2 |
| Part 1: GSK1795091 Repeated 60 ng | Partial Area Under the Concentration-time Curve to Time t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 1 | AUC(0-inf) | 1440 Hours*pg/mL | Geometric Coefficient of Variation 15.9 |
Secondary
Partial Area Under the Concentration-time Curve to Time = t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 2
AUC (0-t) and AUC (0-inf) assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Partial Area Under the Concentration-time Curve to Time = t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 2 | AUC(0-t) | — |
| Unknown | Partial Area Under the Concentration-time Curve to Time = t (AUC[0-t]), Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK1795091 for Part 2 | AUC(0-inf) | — |
Secondary
Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of GCSF. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 48 hour | 6.29 Percent fold change | Standard Deviation 12.038 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 144 hour | 4.74 Percent fold change | Standard Deviation 19.231 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 4 hour | 10.78 Percent fold change | Standard Deviation 18.117 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 16 hour | 5.83 Percent fold change | Standard Deviation 13.164 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 24 hour | 6.67 Percent fold change | Standard Deviation 9.27 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 12 hour | 16.42 Percent fold change | Standard Deviation 20.532 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 2 hour | 2.91 Percent fold change | Standard Deviation 6.204 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 1 hour | -0.99 Percent fold change | Standard Deviation 5.692 |
| Part 1: Placebo | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 8 hour | 19.67 Percent fold change | Standard Deviation 23.987 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 144 hour | -10.01 Percent fold change | Standard Deviation 13.393 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 16 hour | 10.84 Percent fold change | Standard Deviation 18 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 2 hour | 2.69 Percent fold change | Standard Deviation 12.149 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 4 hour | 4.38 Percent fold change | Standard Deviation 9.022 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 1 hour | -4.68 Percent fold change | Standard Deviation 10.515 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 48 hour | 2.52 Percent fold change | Standard Deviation 10.17 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 8 hour | 16.22 Percent fold change | Standard Deviation 12.747 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 24 hour | 4.50 Percent fold change | Standard Deviation 13.016 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 12 hour | 13.85 Percent fold change | Standard Deviation 17.9 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 2 hour | 11.12 Percent fold change | Standard Deviation 11.405 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 16 hour | -2.49 Percent fold change | Standard Deviation 17.532 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 8 hour | 9.78 Percent fold change | Standard Deviation 24.467 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 48 hour | -1.26 Percent fold change | Standard Deviation 10.068 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 144 hour | 7.06 Percent fold change | Standard Deviation 23.343 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 4 hour | 13.23 Percent fold change | Standard Deviation 15.291 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 24 hour | 1.23 Percent fold change | Standard Deviation 10.457 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 12 hour | 8.85 Percent fold change | Standard Deviation 20.773 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 1 hour | 2.58 Percent fold change | Standard Deviation 7.662 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 16 hour | 30.82 Percent fold change | Standard Deviation 39.981 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 1 hour | 2.91 Percent fold change | Standard Deviation 16.607 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 2 hour | 162.85 Percent fold change | Standard Deviation 247.315 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 4 hour | 933.31 Percent fold change | Standard Deviation 1826.357 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 8 hour | 150.61 Percent fold change | Standard Deviation 232.289 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 12 hour | 71.44 Percent fold change | Standard Deviation 71.786 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 24 hour | 23.82 Percent fold change | Standard Deviation 29.497 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 48 hour | 19.14 Percent fold change | Standard Deviation 17.687 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 144 hour | -4.23 Percent fold change | Standard Deviation 16.821 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 12 hour | 59.51 Percent fold change | Standard Deviation 72.401 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 8 hour | 96.07 Percent fold change | Standard Deviation 123.2 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 24 hour | 15.76 Percent fold change | Standard Deviation 36.063 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 4 hour | 390.62 Percent fold change | Standard Deviation 541.504 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 144 hour | -5.25 Percent fold change | Standard Deviation 21.081 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 48 hour | 3.08 Percent fold change | Standard Deviation 25.153 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 2 hour | 105.64 Percent fold change | Standard Deviation 96.885 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 1 hour | 5.83 Percent fold change | Standard Deviation 8.244 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 16 hour | 22.29 Percent fold change | Standard Deviation 55.206 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 1 hour | 25.99 Percent fold change | Standard Deviation 11.22 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 8 hour | 595.98 Percent fold change | Standard Deviation 316.686 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 16 hour | 162.78 Percent fold change | Standard Deviation 121.912 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 144 hour | -4.94 Percent fold change | Standard Deviation 23.01 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 48 hour | 17.08 Percent fold change | Standard Deviation 32.119 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 24 hour | 96.88 Percent fold change | Standard Deviation 87.031 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 4 hour | 3754.71 Percent fold change | Standard Deviation 2439.913 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 12 hour | 265.40 Percent fold change | Standard Deviation 166.832 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Colony Stimulating Factor 2 (GCSF) From Baseline for Part 1 | 2 hour | 1365.60 Percent fold change | Standard Deviation 893.674 |
Secondary
Percentage Fold Change of Concentration of GCSF From Baseline for Part 2
GCSF assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Percentage Fold Change of Concentration of IFN-gamma From Baseline for Part 2
IFN-gamma assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Percentage Fold Change of Concentration of IL-10 From Baseline for Part 2
IL-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.
Secondary
Percentage Fold Change of Concentration of IL-1Ra From Baseline for Part 2
IL-1Ra assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.
Secondary
Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of IP-10. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 48 hour | 6.24 Percent fold change | Standard Deviation 28.068 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 144 hour | 5.97 Percent fold change | Standard Deviation 35.519 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 4 hour | -14.34 Percent fold change | Standard Deviation 11.025 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 16 hour | -14.51 Percent fold change | Standard Deviation 14.185 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 24 hour | -2.89 Percent fold change | Standard Deviation 20.587 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 12 hour | -22.97 Percent fold change | Standard Deviation 8.906 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 2 hour | -15.30 Percent fold change | Standard Deviation 9.675 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 1 hour | -17.09 Percent fold change | Standard Deviation 11.676 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 8 hour | -11.97 Percent fold change | Standard Deviation 10.564 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 144 hour | 20.56 Percent fold change | Standard Deviation 41.682 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 16 hour | -6.75 Percent fold change | Standard Deviation 20.215 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 2 hour | -8.75 Percent fold change | Standard Deviation 16.126 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 4 hour | 25.43 Percent fold change | Standard Deviation 42.934 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 1 hour | -22.96 Percent fold change | Standard Deviation 9.621 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 48 hour | 37.30 Percent fold change | Standard Deviation 78.673 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 8 hour | 4.07 Percent fold change | Standard Deviation 29.521 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 24 hour | 25.65 Percent fold change | Standard Deviation 38.1 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 12 hour | -9.76 Percent fold change | Standard Deviation 17.265 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 2 hour | 39.93 Percent fold change | Standard Deviation 26.514 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 16 hour | 52.55 Percent fold change | Standard Deviation 32.122 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 8 hour | 119.48 Percent fold change | Standard Deviation 103.465 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 48 hour | 31.98 Percent fold change | Standard Deviation 40.635 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 144 hour | 16.66 Percent fold change | Standard Deviation 39.635 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 4 hour | 351.07 Percent fold change | Standard Deviation 286.393 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 24 hour | 46.42 Percent fold change | Standard Deviation 25.692 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 12 hour | 46.78 Percent fold change | Standard Deviation 40.98 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 1 hour | -10.99 Percent fold change | Standard Deviation 11.237 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 16 hour | 99.47 Percent fold change | Standard Deviation 114.305 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 1 hour | -21.97 Percent fold change | Standard Deviation 10.771 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 2 hour | 54.49 Percent fold change | Standard Deviation 58.967 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 4 hour | 1672.77 Percent fold change | Standard Deviation 1676.676 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 8 hour | 338.47 Percent fold change | Standard Deviation 349.007 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 12 hour | 133.47 Percent fold change | Standard Deviation 128.186 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 24 hour | 67.34 Percent fold change | Standard Deviation 34.573 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 48 hour | 35.61 Percent fold change | Standard Deviation 26.802 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 144 hour | 15.62 Percent fold change | Standard Deviation 50.973 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 12 hour | 337.37 Percent fold change | Standard Deviation 416.181 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 8 hour | 538.99 Percent fold change | Standard Deviation 614.669 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 24 hour | 137.55 Percent fold change | Standard Deviation 128.045 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 4 hour | 2045.12 Percent fold change | Standard Deviation 1937.378 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 144 hour | 24.18 Percent fold change | Standard Deviation 21.117 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 48 hour | 41.03 Percent fold change | Standard Deviation 42.609 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 2 hour | 112.79 Percent fold change | Standard Deviation 66.958 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 1 hour | -6.50 Percent fold change | Standard Deviation 12.551 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 16 hour | 238.17 Percent fold change | Standard Deviation 321.382 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 1 hour | 14.49 Percent fold change | Standard Deviation 35.063 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 8 hour | 2367.11 Percent fold change | Standard Deviation 1067.103 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 16 hour | 394.46 Percent fold change | Standard Deviation 171.075 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 144 hour | 29.64 Percent fold change | Standard Deviation 21.33 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 48 hour | 57.44 Percent fold change | Standard Deviation 28.805 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 24 hour | 186.87 Percent fold change | Standard Deviation 57.86 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 4 hour | 6740.10 Percent fold change | Standard Deviation 1888.455 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 12 hour | 802.21 Percent fold change | Standard Deviation 272.436 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Inducible Protein (IP)-10 From Baseline for Part 1 | 2 hour | 312.12 Percent fold change | Standard Deviation 121.798 |
Secondary
Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of IFN-gamma. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 48 hour, n=10, 4, 4, 6, 6, 5 | 4.21 Percent fold change | Standard Deviation 22.768 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 144 hour, n=10, 4, 3, 6, 6, 5 | 33.01 Percent fold change | Standard Deviation 107.893 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 4 hour, n=10, 5, 4, 6, 6, 5 | -2.39 Percent fold change | Standard Deviation 8.391 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 16 hour, n=10, 5, 4, 6, 6, 5 | 6.51 Percent fold change | Standard Deviation 24.803 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 24 hour, n=10, 4, 4, 6, 6, 5 | 3.96 Percent fold change | Standard Deviation 17.217 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 12 hour, n=10, 5, 4, 6, 6, 5 | 4.48 Percent fold change | Standard Deviation 14.14 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 2 hour, n=10, 5, 4, 6, 6, 5 | 5.04 Percent fold change | Standard Deviation 13.885 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 1 hour, n=9, 5, 4, 6, 6, 5 | -1.24 Percent fold change | Standard Deviation 7.942 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 8 hour, n=10, 5, 4, 6, 6, 5 | 0.05 Percent fold change | Standard Deviation 5.453 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 144 hour, n=10, 4, 3, 6, 6, 5 | 4.96 Percent fold change | Standard Deviation 8.947 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 16 hour, n=10, 5, 4, 6, 6, 5 | -6.27 Percent fold change | Standard Deviation 29.923 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 2 hour, n=10, 5, 4, 6, 6, 5 | -7.35 Percent fold change | Standard Deviation 10.068 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 4 hour, n=10, 5, 4, 6, 6, 5 | 2.33 Percent fold change | Standard Deviation 6.932 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 1 hour, n=9, 5, 4, 6, 6, 5 | -6.31 Percent fold change | Standard Deviation 7.547 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 48 hour, n=10, 4, 4, 6, 6, 5 | 1.41 Percent fold change | Standard Deviation 6.871 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 8 hour, n=10, 5, 4, 6, 6, 5 | -0.10 Percent fold change | Standard Deviation 5.957 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 24 hour, n=10, 4, 4, 6, 6, 5 | 6.57 Percent fold change | Standard Deviation 16.853 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 12 hour, n=10, 5, 4, 6, 6, 5 | -7.01 Percent fold change | Standard Deviation 27.233 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 2 hour, n=10, 5, 4, 6, 6, 5 | -0.81 Percent fold change | Standard Deviation 4.453 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 16 hour, n=10, 5, 4, 6, 6, 5 | -15.42 Percent fold change | Standard Deviation 22.05 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 8 hour, n=10, 5, 4, 6, 6, 5 | 13.68 Percent fold change | Standard Deviation 39.549 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 48 hour, n=10, 4, 4, 6, 6, 5 | -19.82 Percent fold change | Standard Deviation 34.669 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 144 hour, n=10, 4, 3, 6, 6, 5 | -2.15 Percent fold change | Standard Deviation 13.149 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 4 hour, n=10, 5, 4, 6, 6, 5 | 49.66 Percent fold change | Standard Deviation 97.641 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 24 hour, n=10, 4, 4, 6, 6, 5 | -19.32 Percent fold change | Standard Deviation 32.943 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 12 hour, n=10, 5, 4, 6, 6, 5 | -9.18 Percent fold change | Standard Deviation 10.54 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 1 hour, n=9, 5, 4, 6, 6, 5 | -3.16 Percent fold change | Standard Deviation 6.918 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 16 hour, n=10, 5, 4, 6, 6, 5 | 20.62 Percent fold change | Standard Deviation 29.976 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 1 hour, n=9, 5, 4, 6, 6, 5 | -1.52 Percent fold change | Standard Deviation 3.299 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 2 hour, n=10, 5, 4, 6, 6, 5 | 17.81 Percent fold change | Standard Deviation 56.864 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 4 hour, n=10, 5, 4, 6, 6, 5 | 119.86 Percent fold change | Standard Deviation 211.426 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 8 hour, n=10, 5, 4, 6, 6, 5 | 36.75 Percent fold change | Standard Deviation 48.057 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 12 hour, n=10, 5, 4, 6, 6, 5 | 20.90 Percent fold change | Standard Deviation 32.53 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 24 hour, n=10, 4, 4, 6, 6, 5 | 2.48 Percent fold change | Standard Deviation 8.071 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 48 hour, n=10, 4, 4, 6, 6, 5 | -3.63 Percent fold change | Standard Deviation 13.448 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 144 hour, n=10, 4, 3, 6, 6, 5 | -4.16 Percent fold change | Standard Deviation 14.851 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 12 hour, n=10, 5, 4, 6, 6, 5 | 38.35 Percent fold change | Standard Deviation 48.687 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 8 hour, n=10, 5, 4, 6, 6, 5 | 86.13 Percent fold change | Standard Deviation 63.258 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 24 hour, n=10, 4, 4, 6, 6, 5 | -3.08 Percent fold change | Standard Deviation 14.045 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 4 hour, n=10, 5, 4, 6, 6, 5 | 247.58 Percent fold change | Standard Deviation 188.954 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 144 hour, n=10, 4, 3, 6, 6, 5 | 6.81 Percent fold change | Standard Deviation 21.544 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 48 hour, n=10, 4, 4, 6, 6, 5 | 0.39 Percent fold change | Standard Deviation 20.837 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 2 hour, n=10, 5, 4, 6, 6, 5 | 72.02 Percent fold change | Standard Deviation 125.017 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 1 hour, n=9, 5, 4, 6, 6, 5 | -8.15 Percent fold change | Standard Deviation 9.43 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 16 hour, n=10, 5, 4, 6, 6, 5 | 34.82 Percent fold change | Standard Deviation 46.979 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 1 hour, n=9, 5, 4, 6, 6, 5 | 14.42 Percent fold change | Standard Deviation 17.175 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 8 hour, n=10, 5, 4, 6, 6, 5 | 66.69 Percent fold change | Standard Deviation 94.96 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 16 hour, n=10, 5, 4, 6, 6, 5 | 12.75 Percent fold change | Standard Deviation 19.418 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 144 hour, n=10, 4, 3, 6, 6, 5 | -1.26 Percent fold change | Standard Deviation 5.652 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 48 hour, n=10, 4, 4, 6, 6, 5 | 2.43 Percent fold change | Standard Deviation 5.216 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 24 hour, n=10, 4, 4, 6, 6, 5 | 6.46 Percent fold change | Standard Deviation 8.403 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 4 hour, n=10, 5, 4, 6, 6, 5 | 229.73 Percent fold change | Standard Deviation 352.909 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 12 hour, n=10, 5, 4, 6, 6, 5 | 31.00 Percent fold change | Standard Deviation 37.179 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interferon (IFN)-Gamma From Baseline for Part 1 | 2 hour, n=10, 5, 4, 6, 6, 5 | 104.54 Percent fold change | Standard Deviation 208.806 |
Secondary
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of IL-6. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. All participants in the All Subjects Population for whom valid and evaluable pharmacodynamic parameters were derived are included in Pharmacodynamic (PD) Population. Data from multiplex immunoassay has been reported.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 24 hour | 129.34 Percent fold change | Standard Deviation 110.041 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 48 hour | -13.13 Percent fold change | Standard Deviation 46.097 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 2 hour | 26.49 Percent fold change | Standard Deviation 39.212 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 4 hour | 169.63 Percent fold change | Standard Deviation 421.394 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 8 hour | 262.38 Percent fold change | Standard Deviation 339.956 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 144 hour | -12.48 Percent fold change | Standard Deviation 27.665 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 12 hour | 267.01 Percent fold change | Standard Deviation 274.112 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 16 hour | 284.52 Percent fold change | Standard Deviation 356.147 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 1 hour | 40.17 Percent fold change | Standard Deviation 51.192 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 16 hour | 607.83 Percent fold change | Standard Deviation 986.76 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 8 hour | 161.33 Percent fold change | Standard Deviation 187.908 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 4 hour | 255.33 Percent fold change | Standard Deviation 254.874 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 24 hour | 200.07 Percent fold change | Standard Deviation 261.81 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 2 hour | 239.27 Percent fold change | Standard Deviation 301.767 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 48 hour | -33.21 Percent fold change | Standard Deviation 30.172 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 12 hour | 832.13 Percent fold change | Standard Deviation 965.345 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 1 hour | 30.81 Percent fold change | Standard Deviation 33.517 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 144 hour | -29.63 Percent fold change | Standard Deviation 38.535 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 1 hour | 193.49 Percent fold change | Standard Deviation 163.904 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 144 hour | -19.58 Percent fold change | Standard Deviation 26.65 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 48 hour | -18.95 Percent fold change | Standard Deviation 45.03 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 4 hour | 513.81 Percent fold change | Standard Deviation 523.303 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 8 hour | 338.13 Percent fold change | Standard Deviation 317.03 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 2 hour | 625.51 Percent fold change | Standard Deviation 547.296 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 16 hour | 249.04 Percent fold change | Standard Deviation 280.046 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 12 hour | 938.35 Percent fold change | Standard Deviation 1585.37 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 24 hour | 56.24 Percent fold change | Standard Deviation 157.132 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 12 hour | 500.75 Percent fold change | Standard Deviation 827.894 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 8 hour | 166.86 Percent fold change | Standard Deviation 176.423 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 2 hour | 1801.82 Percent fold change | Standard Deviation 1788.852 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 24 hour | 182.47 Percent fold change | Standard Deviation 248.911 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 144 hour | -4.52 Percent fold change | Standard Deviation 41.111 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 4 hour | 803.37 Percent fold change | Standard Deviation 1020.453 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 1 hour | 332.92 Percent fold change | Standard Deviation 310.845 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 16 hour | 467.74 Percent fold change | Standard Deviation 620.968 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 48 hour | -21.89 Percent fold change | Standard Deviation 30.042 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 2 hour | 2171.25 Percent fold change | Standard Deviation 1363.074 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 1 hour | 588.11 Percent fold change | Standard Deviation 324.942 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 4 hour | 1244.12 Percent fold change | Standard Deviation 1759.562 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 8 hour | 677.24 Percent fold change | Standard Deviation 903.777 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 12 hour | 644.77 Percent fold change | Standard Deviation 311.661 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 16 hour | 326.81 Percent fold change | Standard Deviation 300.766 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 24 hour | 201.93 Percent fold change | Standard Deviation 375.976 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 48 hour | -14.22 Percent fold change | Standard Deviation 42.014 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 144 hour | -10.87 Percent fold change | Standard Deviation 26.937 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 12 hour | 363.91 Percent fold change | Standard Deviation 610.09 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 144 hour | -6.59 Percent fold change | Standard Deviation 39.036 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 48 hour | -26.67 Percent fold change | Standard Deviation 21.931 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 8 hour | 190.07 Percent fold change | Standard Deviation 181.963 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 4 hour | 1170.88 Percent fold change | Standard Deviation 767.439 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 2 hour | 7305.11 Percent fold change | Standard Deviation 6138.721 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 1 hour | 956.69 Percent fold change | Standard Deviation 763.404 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 24 hour | 160.58 Percent fold change | Standard Deviation 383.092 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 1 | 16 hour | 210.55 Percent fold change | Standard Deviation 425.106 |
Secondary
Percentage Fold Change of Concentration of Interleukin 6 (IL-6) From Baseline for Part 2
IL-6 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Percentage Fold Change of Concentration of IP-10 From Baseline for Part 2
IP-10 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. The data was not collected for Part 2 because no Par. were enrolled into this part of the study.
Secondary
Percentage Fold Change of Concentration of MCP-1 From Baseline for Part 2
MCP-1 assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of MCP-1. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 48 hour | -3.16 Percent fold change | Standard Deviation 12.267 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 144 hour | 13.23 Percent fold change | Standard Deviation 20.203 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 4 hour | -3.44 Percent fold change | Standard Deviation 14.828 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 16 hour | 11.29 Percent fold change | Standard Deviation 17.046 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 24 hour | -6.26 Percent fold change | Standard Deviation 9.139 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 12 hour | 6.99 Percent fold change | Standard Deviation 16.748 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 2 hour | 0.73 Percent fold change | Standard Deviation 9.124 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 1 hour | 0.39 Percent fold change | Standard Deviation 9.459 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 8 hour | 1.97 Percent fold change | Standard Deviation 14.914 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 144 hour | 24.53 Percent fold change | Standard Deviation 11.806 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 16 hour | 29.40 Percent fold change | Standard Deviation 25.521 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 2 hour | 76.83 Percent fold change | Standard Deviation 60.093 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 4 hour | 64.60 Percent fold change | Standard Deviation 54.045 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 1 hour | -1.15 Percent fold change | Standard Deviation 10.591 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 48 hour | -1.40 Percent fold change | Standard Deviation 9.991 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 8 hour | 7.94 Percent fold change | Standard Deviation 17.127 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 24 hour | -1.42 Percent fold change | Standard Deviation 9.045 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 12 hour | 16.17 Percent fold change | Standard Deviation 18.245 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 2 hour | 481.09 Percent fold change | Standard Deviation 255.487 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 16 hour | 26.43 Percent fold change | Standard Deviation 9.956 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 8 hour | 35.25 Percent fold change | Standard Deviation 25.294 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 48 hour | -1.51 Percent fold change | Standard Deviation 9.848 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 144 hour | 22.01 Percent fold change | Standard Deviation 11.379 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 4 hour | 315.88 Percent fold change | Standard Deviation 237.902 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 24 hour | 4.06 Percent fold change | Standard Deviation 7.179 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 12 hour | 29.60 Percent fold change | Standard Deviation 25.748 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 1 hour | 4.50 Percent fold change | Standard Deviation 12.165 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 16 hour | 35.30 Percent fold change | Standard Deviation 25.461 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 1 hour | 18.59 Percent fold change | Standard Deviation 24.366 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 2 hour | 1097.31 Percent fold change | Standard Deviation 743.475 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 4 hour | 907.01 Percent fold change | Standard Deviation 928.98 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 8 hour | 51.16 Percent fold change | Standard Deviation 29.055 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 12 hour | 32.76 Percent fold change | Standard Deviation 23.618 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 24 hour | -7.95 Percent fold change | Standard Deviation 11.24 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 48 hour | -8.02 Percent fold change | Standard Deviation 15.104 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 144 hour | 8.74 Percent fold change | Standard Deviation 24.846 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 12 hour | 56.45 Percent fold change | Standard Deviation 56.466 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 8 hour | 70.82 Percent fold change | Standard Deviation 58.048 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 24 hour | 3.90 Percent fold change | Standard Deviation 14.549 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 4 hour | 1241.68 Percent fold change | Standard Deviation 1744.836 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 144 hour | 14.97 Percent fold change | Standard Deviation 16.939 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 48 hour | -7.40 Percent fold change | Standard Deviation 10.834 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 2 hour | 2604.72 Percent fold change | Standard Deviation 1691.082 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 1 hour | 21.31 Percent fold change | Standard Deviation 30.421 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 16 hour | 39.71 Percent fold change | Standard Deviation 40.794 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 1 hour | 119.24 Percent fold change | Standard Deviation 58.836 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 8 hour | 223.95 Percent fold change | Standard Deviation 113.142 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 16 hour | 45.49 Percent fold change | Standard Deviation 18.571 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 144 hour | 15.23 Percent fold change | Standard Deviation 12.46 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 48 hour | -3.58 Percent fold change | Standard Deviation 10.363 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 24 hour | 10.69 Percent fold change | Standard Deviation 16.458 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 4 hour | 5290.85 Percent fold change | Standard Deviation 2834.623 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 12 hour | 111.19 Percent fold change | Standard Deviation 67.497 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Monocyte Chemotactic Protein 1 (MCP-1) From Baseline for Part 1 | 2 hour | 5883.27 Percent fold change | Standard Deviation 2461.263 |
Secondary
Percentage Fold Change of Concentration of TNF-alpha From Baseline for Part 2
TNF-alpha assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of TNF-alpha. Baseline (Day 1) was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline. Data from multiplex immunoassay has been reported. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 4 hour, n=8, 3, 5, 5, 4, 5 | -4.38 Percent fold change | Standard Deviation 12.448 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 24 hour, n=8, 3, 5, 5, 4, 5 | 3.30 Percent fold change | Standard Deviation 30.223 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 144 hour, n=8, 3, 5, 5, 4, 5 | -7.34 Percent fold change | Standard Deviation 15.006 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 2 hour, n=8, 3, 5, 5, 4, 5 | -1.26 Percent fold change | Standard Deviation 11.879 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 8 hour, n=8, 3, 5, 5, 4, 5 | 1.72 Percent fold change | Standard Deviation 8.69 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 12 hour, n=8, 3, 5, 5, 4, 5 | 4.38 Percent fold change | Standard Deviation 19.376 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 16 hour, n=8, 3, 5, 5, 4, 5 | -1.81 Percent fold change | Standard Deviation 17.321 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 48 hour, n=8, 3, 5, 5, 3, 5 | -2.56 Percent fold change | Standard Deviation 16.028 |
| Part 1: Placebo | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 1 hour, n=8, 3, 5, 5, 4, 5 | 3.61 Percent fold change | Standard Deviation 28.753 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 24 hour, n=8, 3, 5, 5, 4, 5 | -10.02 Percent fold change | Standard Deviation 21.221 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 12 hour, n=8, 3, 5, 5, 4, 5 | -10.33 Percent fold change | Standard Deviation 26.632 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 48 hour, n=8, 3, 5, 5, 3, 5 | -7.18 Percent fold change | Standard Deviation 9.567 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 1 hour, n=8, 3, 5, 5, 4, 5 | 12.51 Percent fold change | Standard Deviation 22.453 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 8 hour, n=8, 3, 5, 5, 4, 5 | -12.56 Percent fold change | Standard Deviation 13.872 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 2 hour, n=8, 3, 5, 5, 4, 5 | -6.42 Percent fold change | Standard Deviation 5.229 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 144 hour, n=8, 3, 5, 5, 4, 5 | -2.90 Percent fold change | Standard Deviation 20.283 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 4 hour, n=8, 3, 5, 5, 4, 5 | -5.82 Percent fold change | Standard Deviation 8.277 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 16 hour, n=8, 3, 5, 5, 4, 5 | -11.77 Percent fold change | Standard Deviation 16.419 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 1 hour, n=8, 3, 5, 5, 4, 5 | 112.63 Percent fold change | Standard Deviation 185.111 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 16 hour, n=8, 3, 5, 5, 4, 5 | 17.36 Percent fold change | Standard Deviation 92.732 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 12 hour, n=8, 3, 5, 5, 4, 5 | 54.30 Percent fold change | Standard Deviation 170.246 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 48 hour, n=8, 3, 5, 5, 3, 5 | -10.99 Percent fold change | Standard Deviation 37.153 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 4 hour, n=8, 3, 5, 5, 4, 5 | 164.74 Percent fold change | Standard Deviation 402.327 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 24 hour, n=8, 3, 5, 5, 4, 5 | 17.39 Percent fold change | Standard Deviation 75.367 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 144 hour, n=8, 3, 5, 5, 4, 5 | -14.85 Percent fold change | Standard Deviation 27.169 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 2 hour, n=8, 3, 5, 5, 4, 5 | 209.17 Percent fold change | Standard Deviation 437.355 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 8 hour, n=8, 3, 5, 5, 4, 5 | 75.34 Percent fold change | Standard Deviation 202.57 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 48 hour, n=8, 3, 5, 5, 3, 5 | 4.03 Percent fold change | Standard Deviation 23.03 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 144 hour, n=8, 3, 5, 5, 4, 5 | -2.10 Percent fold change | Standard Deviation 37.702 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 1 hour, n=8, 3, 5, 5, 4, 5 | 130.88 Percent fold change | Standard Deviation 126.286 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 2 hour, n=8, 3, 5, 5, 4, 5 | 51.85 Percent fold change | Standard Deviation 58.482 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 4 hour, n=8, 3, 5, 5, 4, 5 | 12.90 Percent fold change | Standard Deviation 22.215 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 8 hour, n=8, 3, 5, 5, 4, 5 | 2.28 Percent fold change | Standard Deviation 4.332 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 12 hour, n=8, 3, 5, 5, 4, 5 | 7.61 Percent fold change | Standard Deviation 10.968 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 16 hour, n=8, 3, 5, 5, 4, 5 | -1.28 Percent fold change | Standard Deviation 9.826 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 24 hour, n=8, 3, 5, 5, 4, 5 | 7.26 Percent fold change | Standard Deviation 13.568 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 12 hour, n=8, 3, 5, 5, 4, 5 | 24.14 Percent fold change | Standard Deviation 35.746 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 4 hour, n=8, 3, 5, 5, 4, 5 | 66.55 Percent fold change | Standard Deviation 76.017 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 16 hour, n=8, 3, 5, 5, 4, 5 | 43.11 Percent fold change | Standard Deviation 90.323 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 2 hour, n=8, 3, 5, 5, 4, 5 | 379.87 Percent fold change | Standard Deviation 299.578 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 1 hour, n=8, 3, 5, 5, 4, 5 | 771.06 Percent fold change | Standard Deviation 579.613 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 48 hour, n=8, 3, 5, 5, 3, 5 | -2.31 Percent fold change | Standard Deviation 45.586 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 24 hour, n=8, 3, 5, 5, 4, 5 | 34.79 Percent fold change | Standard Deviation 37.921 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 8 hour, n=8, 3, 5, 5, 4, 5 | 11.12 Percent fold change | Standard Deviation 32.576 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 144 hour, n=8, 3, 5, 5, 4, 5 | 5.46 Percent fold change | Standard Deviation 31.91 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 1 hour, n=8, 3, 5, 5, 4, 5 | 1838.09 Percent fold change | Standard Deviation 2790.783 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 12 hour, n=8, 3, 5, 5, 4, 5 | -4.21 Percent fold change | Standard Deviation 9.459 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 4 hour, n=8, 3, 5, 5, 4, 5 | 18.87 Percent fold change | Standard Deviation 26.716 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 24 hour, n=8, 3, 5, 5, 4, 5 | -6.04 Percent fold change | Standard Deviation 17.245 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 2 hour, n=8, 3, 5, 5, 4, 5 | 661.61 Percent fold change | Standard Deviation 998.133 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 48 hour, n=8, 3, 5, 5, 3, 5 | -13.33 Percent fold change | Standard Deviation 14.853 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 144 hour, n=8, 3, 5, 5, 4, 5 | -5.16 Percent fold change | Standard Deviation 17.479 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 16 hour, n=8, 3, 5, 5, 4, 5 | -11.41 Percent fold change | Standard Deviation 14.569 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Concentration of Tumor Necrosis Factor (TNF)-Alpha From Baseline for Part 1 | 8 hour, n=8, 3, 5, 5, 4, 5 | -7.87 Percent fold change | Standard Deviation 10.985 |
Secondary
Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of IL-10. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 48 hour | 13.20 Percent fold change | Standard Deviation 45.366 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 144 hour | 17.99 Percent fold change | Standard Deviation 38.91 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 4 hour | 7.66 Percent fold change | Standard Deviation 9.351 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 16 hour | 8.81 Percent fold change | Standard Deviation 23.057 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 24 hour | 14.43 Percent fold change | Standard Deviation 24.246 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 12 hour | -0.94 Percent fold change | Standard Deviation 11.658 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 2 hour | 3.89 Percent fold change | Standard Deviation 5.943 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 1 hour | 4.18 Percent fold change | Standard Deviation 2.923 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 8 hour | 1.45 Percent fold change | Standard Deviation 9.681 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 144 hour | 15.53 Percent fold change | Standard Deviation 13.54 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 16 hour | 13.70 Percent fold change | Standard Deviation 20.597 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 2 hour | 138.05 Percent fold change | Standard Deviation 233.654 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 4 hour | 35.74 Percent fold change | Standard Deviation 39.419 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 1 hour | 36.13 Percent fold change | Standard Deviation 50.565 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 48 hour | 4.98 Percent fold change | Standard Deviation 5.925 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 8 hour | 13.56 Percent fold change | Standard Deviation 22.309 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 24 hour | 6.07 Percent fold change | Standard Deviation 9.298 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 12 hour | 4.52 Percent fold change | Standard Deviation 18.393 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 2 hour | 496.20 Percent fold change | Standard Deviation 746.15 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 16 hour | 23.52 Percent fold change | Standard Deviation 32.664 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 8 hour | 44.31 Percent fold change | Standard Deviation 54.738 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 48 hour | -1.41 Percent fold change | Standard Deviation 11.832 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 144 hour | 10.35 Percent fold change | Standard Deviation 12.876 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 4 hour | 72.32 Percent fold change | Standard Deviation 81.429 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 24 hour | 11.37 Percent fold change | Standard Deviation 17.257 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 12 hour | 22.10 Percent fold change | Standard Deviation 30.976 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 1 hour | 131.03 Percent fold change | Standard Deviation 167.082 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 16 hour | 25.13 Percent fold change | Standard Deviation 19.212 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 1 hour | 170.79 Percent fold change | Standard Deviation 130.626 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 2 hour | 437.92 Percent fold change | Standard Deviation 436.69 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 4 hour | 75.74 Percent fold change | Standard Deviation 75.003 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 8 hour | 38.31 Percent fold change | Standard Deviation 30.005 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 12 hour | 18.10 Percent fold change | Standard Deviation 20.319 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 24 hour | 16.47 Percent fold change | Standard Deviation 10.573 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 48 hour | 9.63 Percent fold change | Standard Deviation 5.995 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 144 hour | 11.73 Percent fold change | Standard Deviation 4.742 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 12 hour | 39.32 Percent fold change | Standard Deviation 35.208 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 8 hour | 98.31 Percent fold change | Standard Deviation 80.14 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 24 hour | 24.70 Percent fold change | Standard Deviation 25.961 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 4 hour | 104.81 Percent fold change | Standard Deviation 83.542 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 144 hour | 14.73 Percent fold change | Standard Deviation 19.17 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 48 hour | -0.10 Percent fold change | Standard Deviation 8.984 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 2 hour | 587.14 Percent fold change | Standard Deviation 327.563 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 1 hour | 320.02 Percent fold change | Standard Deviation 171.738 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 16 hour | 48.07 Percent fold change | Standard Deviation 34.705 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 1 hour | 590.82 Percent fold change | Standard Deviation 378.761 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 8 hour | 152.84 Percent fold change | Standard Deviation 125.207 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 16 hour | 36.84 Percent fold change | Standard Deviation 22.787 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 144 hour | 7.28 Percent fold change | Standard Deviation 10.035 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 48 hour | 2.73 Percent fold change | Standard Deviation 10.103 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 24 hour | 21.83 Percent fold change | Standard Deviation 17.997 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 4 hour | 166.23 Percent fold change | Standard Deviation 149.184 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 12 hour | 46.01 Percent fold change | Standard Deviation 29.984 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 10 (IL-10) From Baseline for Part 1 | 2 hour | 2985.38 Percent fold change | Standard Deviation 2768.658 |
Secondary
Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1
Blood samples were collected at indicated time points for the assessment of IL-1Ra. Baseline was taken as the mean of the planned pre-dose measurements. Change from Baseline was defined as difference between the post-Baseline visit value and the Baseline value. Percentage fold change equals to 100\*change from Baseline divided by Baseline.
Time frame: Baseline, 1, 2, 4, 8, 12, 16, 24, 48 and 144 hours
Population: PD Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 48 hour | -11.07 Percent fold change | Standard Deviation 23.224 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 144 hour | -2.00 Percent fold change | Standard Deviation 35.912 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 4 hour | 13.43 Percent fold change | Standard Deviation 24.391 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 16 hour | 29.17 Percent fold change | Standard Deviation 28.404 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 24 hour | 35.02 Percent fold change | Standard Deviation 51.217 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 12 hour | 21.64 Percent fold change | Standard Deviation 23.58 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 2 hour | 5.26 Percent fold change | Standard Deviation 17.249 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 1 hour | 4.06 Percent fold change | Standard Deviation 12.046 |
| Part 1: Placebo | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 8 hour | 20.78 Percent fold change | Standard Deviation 28.762 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 144 hour | -0.95 Percent fold change | Standard Deviation 19.617 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 16 hour | 61.72 Percent fold change | Standard Deviation 38.867 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 2 hour | 26.95 Percent fold change | Standard Deviation 19.1 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 4 hour | 196.62 Percent fold change | Standard Deviation 186.603 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 1 hour | -1.63 Percent fold change | Standard Deviation 15.193 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 48 hour | -3.86 Percent fold change | Standard Deviation 13.848 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 8 hour | 103.59 Percent fold change | Standard Deviation 63.317 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 24 hour | 19.31 Percent fold change | Standard Deviation 36.307 |
| Part 1: GSK1795091 7 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 12 hour | 99.49 Percent fold change | Standard Deviation 75.059 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 2 hour | 149.20 Percent fold change | Standard Deviation 53.633 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 16 hour | 217.81 Percent fold change | Standard Deviation 154.263 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 8 hour | 818.24 Percent fold change | Standard Deviation 578.438 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 48 hour | 10.45 Percent fold change | Standard Deviation 25.851 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 144 hour | -2.03 Percent fold change | Standard Deviation 19.87 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 4 hour | 1716.81 Percent fold change | Standard Deviation 1046.69 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 24 hour | 75.80 Percent fold change | Standard Deviation 64.742 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 12 hour | 360.87 Percent fold change | Standard Deviation 233.664 |
| Part 1: GSK1795091 21 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 1 hour | 11.49 Percent fold change | Standard Deviation 8.978 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 16 hour | 524.89 Percent fold change | Standard Deviation 652.117 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 1 hour | 19.88 Percent fold change | Standard Deviation 23.137 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 2 hour | 607.17 Percent fold change | Standard Deviation 611.511 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 4 hour | 12062.23 Percent fold change | Standard Deviation 13307.136 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 8 hour | 3136.61 Percent fold change | Standard Deviation 3429.187 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 12 hour | 1207.18 Percent fold change | Standard Deviation 1324.133 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 24 hour | 124.90 Percent fold change | Standard Deviation 154.983 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 48 hour | 7.64 Percent fold change | Standard Deviation 28.049 |
| Part 1: GSK1795091 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 144 hour | 3.17 Percent fold change | Standard Deviation 33.828 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 12 hour | 1422.66 Percent fold change | Standard Deviation 1254.465 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 8 hour | 2788.30 Percent fold change | Standard Deviation 2101.015 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 24 hour | 195.35 Percent fold change | Standard Deviation 136.345 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 4 hour | 13359.29 Percent fold change | Standard Deviation 9271.512 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 144 hour | 3.26 Percent fold change | Standard Deviation 14.855 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 48 hour | 15.71 Percent fold change | Standard Deviation 18.469 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 2 hour | 803.47 Percent fold change | Standard Deviation 486.468 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 1 hour | 38.00 Percent fold change | Standard Deviation 20.565 |
| Part 1: GSK1795091 Repeated 60 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 16 hour | 723.30 Percent fold change | Standard Deviation 718.195 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 1 hour | 111.99 Percent fold change | Standard Deviation 25.295 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 8 hour | 16830.47 Percent fold change | Standard Deviation 7106.072 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 16 hour | 2273.75 Percent fold change | Standard Deviation 783.885 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 144 hour | 2.75 Percent fold change | Standard Deviation 13.556 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 48 hour | 37.51 Percent fold change | Standard Deviation 17.058 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 24 hour | 400.73 Percent fold change | Standard Deviation 98.553 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 4 hour | 105032.57 Percent fold change | Standard Deviation 61423.988 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 12 hour | 7055.35 Percent fold change | Standard Deviation 3496.863 |
| Part 1: GSK1795091 100 ng | Percentage Fold Change of Interleukin 1 Receptor Antagonist (IL-1Ra) From Baseline for Part 1 | 2 hour | 7054.40 Percent fold change | Standard Deviation 1029.027 |
Secondary
Time Invariance of GSK1795091 for Part 2
Time invariance assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. NA indicates data was not available for 7 ng Arm as all concentration outcomes at 7 ng were not quantifiable because all results were below the limit of quantification.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | t1/2 | NA Hours | — |
| Part 1: Placebo | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | tmax | NA Hours | — |
| Part 1: GSK1795091 7 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | t1/2 | 25.2 Hours | Standard Deviation 9.51 |
| Part 1: GSK1795091 7 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | tmax | 0.0950 Hours | Standard Deviation 0.0197 |
| Part 1: GSK1795091 21 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | t1/2 | 45.7 Hours | Standard Deviation 12.5 |
| Part 1: GSK1795091 21 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | tmax | 0.0833 Hours | Standard Deviation 0.00816 |
| Part 1: GSK1795091 60 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | tmax | 0.103 Hours | Standard Deviation 0.0755 |
| Part 1: GSK1795091 60 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | t1/2 | 67.1 Hours | Standard Deviation 33.9 |
| Part 1: GSK1795091 Repeated 60 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | t1/2 | 69.4 Hours | Standard Deviation 9.24 |
| Part 1: GSK1795091 Repeated 60 ng | Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 1 | tmax | 0.0880 Hours | Standard Deviation 0.011 |
Secondary
Time of Occurrence of Cmax (Tmax) and Terminal Half Life (t1/2) of GSK1795091 for Part 2
Tmax and t1/2 assessments were planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.
Secondary
Volume of Distribution of GSK1795091 for Part 1
Blood samples were collected at indicated time points. The PK parameters were calculated for each participant using a non-compartmental method. Only those participants with data available at the specified data points were analyzed.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. NA indicates data was not available as all concentration outcomes at 7ng were not quantifiable because all results were below the limit of quantification.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Placebo | Volume of Distribution of GSK1795091 for Part 1 | NA Liters (L) | — |
| Part 1: GSK1795091 7 ng | Volume of Distribution of GSK1795091 for Part 1 | 6.95 Liters (L) | Geometric Coefficient of Variation 10.1 |
| Part 1: GSK1795091 21 ng | Volume of Distribution of GSK1795091 for Part 1 | 9.46 Liters (L) | Geometric Coefficient of Variation 24.2 |
| Part 1: GSK1795091 60 ng | Volume of Distribution of GSK1795091 for Part 1 | 9.95 Liters (L) | Geometric Coefficient of Variation 25.7 |
| Part 1: GSK1795091 Repeated 60 ng | Volume of Distribution of GSK1795091 for Part 1 | 6.75 Liters (L) | Geometric Coefficient of Variation 10.7 |
Secondary
Volume of Distribution of GSK1795091 for Part 2
Volume of distribution assessment was planned for Part 2 after IV dose administration to healthy participants 1 or 2 Weeks after the first dose. The data for Part 2 of the study was not collected as the study was discontinued by the Sponsor prior to its scheduled start due to participant in Part 1 experienced the late occurrence of AEs of unknown etiology.
Time frame: Pre-dose, 5 minutes, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, and 144 hours post-dose
Population: PK Parameter Population. Data was not collected for Part 2 as none of the participant was enrolled into Part 2 of the study.