Coccidioidomycosis
Conditions
Keywords
Adults, Healthy, Pharmacokinetics, Phase 1, Safety, Single Oral Doses, Tolerability, VT-1598
Brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy adult subjects ages 18 - 45 years inclusive. It is designed to evaluate the safety and PK of single oral doses of VT-1598. Forty-eight subjects will be enrolled in the study at 1 site in the US and randomized to receive either VT-1598 or placebo in 6 dosage cohorts (five fasted cohorts and one fed cohort). Each cohort will have 8 subjects; 6 subjects will receive a single oral dose of VT-1598 and 2 subjects will receive matching placebo. Cohorts 1 - 5 will include 2 sentinel subjects randomized to different treatments. Cohort 6 (receiving treatment after being fed a high-calorie, high-fat meal) will not include sentinel subjects. Subjects will be admitted to the study site before dosing and remain at the study site for safety monitoring and PK assessments for at least 72 hours post-dose. Subjects will return to the study site on study Days 7, 14, and 21 for outpatient safety monitoring and PK assessments. There are no formal hypotheses being tested in this Phase 1 trial study. The primary objectives of this study are 1) to determine the safety of single-ascending oral doses of VT-1598 in healthy adult subjects in a fasted state, and 2) to determine the safety of single oral dose of VT-1598 in healthy adult subjects in a fed state.
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in healthy adult subjects ages 18 - 45 years inclusive. It is designed to evaluate the safety and PK of single oral doses of VT-1598. Forty-eight subjects will be enrolled in the study at 1 site in the US and randomized to receive either VT-1598 or placebo in 6 dosage cohorts (five fasted cohorts and one fed cohort). Cohorts 1 - 4 will run sequentially, but Cohorts 5 and 6 may be started concurrently. Each cohort will have 8 subjects; 6 subjects will receive a single oral dose of VT-1598 and 2 subjects will receive matching placebo. Cohorts 1 - 5 will include 2 sentinel subjects randomized to different treatments. Cohort 6 (receiving treatment after being fed a high-calorie, high-fat meal) will not include sentinel subjects. VT-1598 will be administered in the following escalation schedule: Cohort 1 will receive 40 mg dose, Cohort 2 will receive 80 mg dose, Cohort 3 will receive 160 mg dose, Cohort 4 will receive 320 mg dose, Cohort 5 will receive 640 mg dose, and Cohort 6 (fed cohort) will receive 160 mg dose. Subjects will be admitted to the study site before dosing and remain at the study site for safety monitoring and PK assessments for at least 72 hours post-dose. Subjects will return to the study site on study Days 7, 14, and 21 for outpatient safety monitoring and PK assessments. There are no formal hypotheses being tested in this Phase 1 trial study. The primary objectives of this study are 1) to determine the safety of single-ascending oral doses of VT-1598 in healthy adult subjects in a fasted state, and 2) to determine the safety of single oral dose of VT-1598 in healthy adult subjects in a fed state. The secondary objectives of this study are 1) to determine the pharmacokinetic (PK) profile in plasma and urine of VT-1598 and its primary metabolite, VT-11134, in healthy adult subjects, and 2) to determine the effect of a high-fat, high-calorie meal on the PK profile of VT-1598 and VT-11134 when a single oral dose of VT-1598 is given.
Interventions
OTHERPlacebo
Placebo will be supplied as matching tablets (to 40 mg and 80 mg VT-1598 tablets) containing the inactive components of VT-1598.
DRUGVT-1598
VT-1598 is a novel oral agent for the treatment of fungal infections. It will be supplied as 40 mg and 80 mg tablets.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to provide written informed consent and authorization for use of protected health information. 2. Willing and able to comply with protocol requirements, instructions, and protocol-stated restrictions (including confinement to the Clinical Research Unit (CRU)) and is likely to complete the study as planned. 3. Male or female subjects, 18 - 45 years of age (inclusive). 4. Subject is in good health to be safely enrolled in this protocol as determined by medical history and physical exam. 5. Body Mass Index (BMI) of 18 - 35 kg / m\^2, inclusive, and minimum weight of 50 kg. 6. If a female participant is of childbearing potential\*, she must use a highly effective contraceptive method\*\* from 30 days before enrollment through the 3 months after dosing. \*A woman is considered of childbearing potential unless post-menopausal (subject is at least 50 years old and has history of \>/=2 years without menses without other known or suspected cause and has a Follicle Stimulating Hormone (FSH) level \>40 IU/L), or permanently surgically sterilized. \*\*A highly effective contraceptive method includes surgical sterilization methods such as tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful tubal obliteration (e.g., Essure(R)) with documented radiological confirmation test at least 90 days after the procedure, or long-acting reversible contraception (progestin-releasing subdermal implants, copper intrauterine devices (IUDs), levonorgesterel-releasing IUDs). 7. Males\* having sexual intercourse with women of childbearing potential must agree to consistent use of condoms from study product administration through 3 months after dosing\*\*. \*Including vasectomized men. \*\*And must also agree to not donate sperm during the same time period. 8. Subject has adequate venous access for blood collection.
Exclusion criteria
1. Has a chronic condition that may increase risk to subject or interfere with endpoint assessment (e.g., liver disease, kidney disease, immunodeficiency). 2. Chronic condition diagnosed within 90 days of the screening visit. 3. Unstable chronic disease\* within 6 months of the screening visit. \*As defined by need for medical intervention that lead to a change in medications and/or required hospitalization, surgery/procedure, or ED/urgent care visit 4. History of psychiatric condition that has required hospitalization in the last 5 years or patient is considered unstable by study investigator. 5. Any condition that in the opinion of the Investigator could significantly impact drug absorption, distribution, or elimination. 6. Any out of normal range laboratory value\* at screening or enrollment. \*A laboratory value that is Grade 1 (with the exception of alanine aminotransferase (ALT), aspartate aminotransferase (AST), Total bilirubin, hemoglobin or serum creatinine) will be allowed if not considered to be clinically significant by the investigator. 7. Abnormal Electrocardiograms (ECGs). 8. Electrocardiographic QTcF interval \>430 msec for males and \>450 msec for females at Screening. 9. Positive test for antibodies to Human Immunodeficiency Virus-1 (HIV-1), Human Immunodeficiency Virus-2 (HIV-2), Hepatitis B surface antigen (HBsAg), or Hepatitis C (HCV). 10. Positive urine drug test. The drugs that will be screened for includes amphetamines, barbiturates , cocaine, opiates, cannabinoids, phencyclidine, and benzodiazepines. 11. Female subject of childbearing potential who is pregnant\*, lactating, or planning to become pregnant during the study period or 3 months after the final dose of study product. \*Having a positive serum pregnancy test at the Screening Visit or any other specified time point prior to the dose of study product. 12. Received any study product in a clinical trial within 30 days prior to Screening. 13. Admitted or documented illicit drug use or alcohol abuse within 6 months prior to Screening or during their participation in the trial. 14. Consumed alcohol within 72 hours of Day -1, until after the visit to the Clinical Research Unit (CRU) on Day 14 or have a positive alcohol test at Screening or on admission to the CRU. 15. Tobacco\* use within 90 days prior to the Screening Visit or while a subject is enrolled in the study or a positive urine drug test for cotinine. \*Tobacco use includes vaping, smoking tobacco, the use of snuff and chewing tobacco, and other nicotine or nicotine- containing products 16. Use of prescription drugs within 14 days prior to the dose of study product with the exception of hormonal contraceptives, which are permitted throughout the study. 17. Received any non-prescription medications, vitamins, or dietary supplements\* within 7 days of dosing, unless prior approval is granted by both the Investigator and the Sponsor. \*Excluded from this list is intermittent use of acetaminophen at doses of \< / = 2 g / day or ibuprofen \< / = 1200 mg / day. Herbal supplements must be discontinued 7 days prior to the dose of the study product. 18. History of intolerance or hypersensitivity to azole antifungals. 19. Blood donation or other significant blood loss within 60 days of screening and for the duration of the study. 20. Inability or difficulty swallowing whole capsules/tablets and/or multiple capsules/tablets. 21. Consumption of beverages and foods containing caffeine for 24 hours prior to Day -1 until discharge from the CRU on Day 4. 22. Consumption of grapefruit, or juices containing grapefruit or Seville oranges within 7 days prior to the scheduled dose of the study product until after the visit to the CRU on Day 14. 23. Subject has plans to enroll or is already enrolled in another clinical trial that could interfere with safety assessment of the investigational product at any time during the study period\*. \*Includes trials that have a study intervention such as a drug, biologic, or device 24. Having dietary restrictions that would preclude the subject from participating in either fed or fasting cohorts. 25. Having sensitivity or allergy to aspirin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unsolicited Adverse Events | Day 1 through Day 21 | Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each subject was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened. |
| Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Baseline (Day -1) through Day 21 | Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 308 U/L (male) or \>=192 U/L (female), phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 130 IU/L (males) or \>= 105 IU/L (female), aspartate aminotransferase \>= 39.9 U/L (male) or \>= 31.9 U/L (female), alanine aminotransferase \>=40.9 U/L (male) or \>= 32.9 U/L (female), total bilirubin \>=1.2 mg/dL, direct bilirubin \>=0.2 mg/dL, magnesium \<=1.6 mg/dL, and serum cortisol \<= 4 ug/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity. |
| Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Baseline (Day -1) through Day 21 | Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), lymphocyte count \<= 799 cell/mm3, neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, platelet count \<= 150 x 10\^3/mm3, red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), and white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Males) or \>= 11,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Females) or \>= 10,001 cell/mm3 or \<= 3,999 cell/mm3 (all others). If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity. |
| Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Baseline (Day -1) through Day 21 | Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.6 s, PTT \>= 30.1 s, INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity. |
| Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | Baseline (Day -1) through Day 21 | The only graded urinalysis laboratory parameter was red blood cells (RBC) by complete urinalysis. The threshold for adverse events was considered as \>=3. If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | Day 1 through Day 21 | Each participant is only counted once per toxicity grade for the worst severity recorded. The only ECG parameter graded was QTcF interval with a threshold of \>= 30 msec. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity. |
| Number of Participants With Abnormal Vital Signs | Baseline (Day -1) through Day 21 | Each participant is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, pulse, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, pulse \<= 54 bpm (baseline \> 60 bpm) or \<=50 (baseline \<= 60 bpm) or \>= 101 bpm, respiratory rate \>= 17 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the dose-normalized AUC(0-last) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the AUC(0-inf) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the dose normalized AUC(0-inf) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the lambda Z (1/h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| VT-1598 Concentrations in Plasma | 0 hours (h), 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose | Mean and standard deviation of VT-1598 concentrations in plasma by nominal time point. |
| Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the Vd/F (L) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | 0 h through 72 h post dose | Mean and (minimum, maximum) of the amount of VT-1598 and VT-11134 excreted into urine from time zero to the time of the last quantifiable concentration. |
| Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0 h through 72 h post dose | Mean and (minimum, maximum) of the percent of VT-1598 excreted into urine. |
| Renal Clearance (CLr) of VT-1598 and VT-11134 | 0 h through 72 h post dose | Mean and standard deviation (SD) of CLr (mL/min) of VT-1598 and VT-11134. |
| Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the CL/F (L/h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| VT-11134 Concentrations in Plasma | 0 h, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose | Mean and standard deviation of VT-11134 concentrations in plasma by nominal time point. |
| Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data. |
| Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the dose-normalized Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data. |
| Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the Tmax (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data. |
| Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the t 1/2 (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
| Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | 0 h through 480 h post dose | Mean and standard deviation (SD) of the AUC(0-last) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax. |
Countries
United States
Participant flow
Recruitment details
Participants included healthy adult male and female subjects aged 18-45 (inclusive). Participants were recruited from the local community to ensure that male, female, and minorities (African American, Native American, Asian, and Hispanics) were represented in the enrolled population. Participants were enrolled between 29SEP2020 and 17NOV2021.
Participants by arm
| Arm | Count |
|---|---|
| 40 mg Fasted 40 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. | 6 |
| 80 mg Fasted 80 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. | 6 |
| 160 mg Fasted 160 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. | 6 |
| 160 mg Fed 160 mg of VT-1598 administered orally as a single dose, after a high-calorie, high-fat meal on Day 1 in a double-blind manner. | 6 |
| 320 mg Fasted 320 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. | 6 |
| 640 mg Fasted 640 mg of VT-1598 administered orally as a single dose, while fasting on Day 1 in a double-blind manner. | 6 |
| Placebo Placebo participants across all cohorts given matching placebo administered orally as a single dose in a double-blind manner. | 12 |
| Total | 48 |
Baseline characteristics
| Characteristic | 40 mg Fasted | Total | Placebo | 640 mg Fasted | 320 mg Fasted | 160 mg Fed | 160 mg Fasted | 80 mg Fasted |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 32.7 years STANDARD_DEVIATION 6.4 | 35.5 years STANDARD_DEVIATION 6.1 | 33.3 years STANDARD_DEVIATION 6.1 | 38.3 years STANDARD_DEVIATION 6.3 | 38.3 years STANDARD_DEVIATION 8.9 | 39.5 years STANDARD_DEVIATION 3.4 | 34.5 years STANDARD_DEVIATION 2.4 | 33.8 years STANDARD_DEVIATION 5.2 |
| Body Mass Index (BMI) | 26.17 kg/m^2 STANDARD_DEVIATION 4.23 | 28.47 kg/m^2 STANDARD_DEVIATION 3.86 | 29.07 kg/m^2 STANDARD_DEVIATION 3.1 | 30.05 kg/m^2 STANDARD_DEVIATION 5.11 | 28.95 kg/m^2 STANDARD_DEVIATION 4.28 | 26.47 kg/m^2 STANDARD_DEVIATION 3.09 | 27.18 kg/m^2 STANDARD_DEVIATION 2.38 | 30.83 kg/m^2 STANDARD_DEVIATION 4.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 27 Participants | 6 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 19 Participants | 5 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 163.23 cm STANDARD_DEVIATION 5.51 | 168.74 cm STANDARD_DEVIATION 11.42 | 174.16 cm STANDARD_DEVIATION 12.14 | 168.33 cm STANDARD_DEVIATION 11.65 | 166.05 cm STANDARD_DEVIATION 14.13 | 170.75 cm STANDARD_DEVIATION 13.51 | 163.63 cm STANDARD_DEVIATION 8.47 | 169.62 cm STANDARD_DEVIATION 11.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 15 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 33 Participants | 8 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 20 Participants | 4 Participants | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 28 Participants | 8 Participants | 4 Participants | 3 Participants | 3 Participants | 2 Participants | 4 Participants |
| Weight | 70.28 kg STANDARD_DEVIATION 15.26 | 81.55 kg STANDARD_DEVIATION 16.26 | 88.41 kg STANDARD_DEVIATION 14.76 | 84.42 kg STANDARD_DEVIATION 12.74 | 80.32 kg STANDARD_DEVIATION 18.76 | 77.77 kg STANDARD_DEVIATION 16.98 | 72.70 kg STANDARD_DEVIATION 6.88 | 90.08 kg STANDARD_DEVIATION 21.19 |
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 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 6 / 6 | 5 / 6 | 3 / 6 | 5 / 6 | 11 / 12 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 |
Outcome results
Primary
Number of Participants With Abnormal Chemistry Laboratory Toxicity Results
Laboratory parameters and associated thresholds include albumin \<=3.4 g/dL, glucose \<= 69 mg/dL or \>=106 mg/dL, blood urea nitrogen (BUN) \>= 21 mg/dL, potassium \>=5.2 mEq/L or \<=3.4 mEq/L, calcium \< 8.7 mg/dL or \>=10.3 mg/dL, sodium \<=132 mEq/L or \>=144 mEq/L, total protein \<=5.9 g/dL, creatinine \>=1.3 mg/dL (male) or \>= 1.0 mg/dL (female), creatine phosphokinase \>= 308 U/L (male) or \>=192 U/L (female), phosphorus \<=2.4 mg/dL, alkaline phosphatase \>= 130 IU/L (males) or \>= 105 IU/L (female), aspartate aminotransferase \>= 39.9 U/L (male) or \>= 31.9 U/L (female), alanine aminotransferase \>=40.9 U/L (male) or \>= 32.9 U/L (female), total bilirubin \>=1.2 mg/dL, direct bilirubin \>=0.2 mg/dL, magnesium \<=1.6 mg/dL, and serum cortisol \<= 4 ug/dL. If a clinical chemistry laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Time frame: Baseline (Day -1) through Day 21
Population: Safety Population: All participants that received any amount of study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 4 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 2 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 2 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 3 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 1 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 1 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 1 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 1 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 1 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 2 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 3 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 1 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 2 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 1 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 2 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 3 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 1 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatinine, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Creatine Phosphokinase, Increase | 4 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Increase | 2 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Magnesium, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Phosphorus, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Calcium, Decrease | 3 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Albumin, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alkaline Phosphatase, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Increase | 2 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Aspartate Aminotransferase, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Potassium, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Alanine Aminotransferase, Increase | 1 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Blood Urea Nitrogen, Increase | 1 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Serum Cortisol, Decrease | 2 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Bilirubin, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Increase | 4 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Direct Bilirubin, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Glucose, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Total Protein, Decrease | 3 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Chemistry Laboratory Toxicity Results | Sodium, Decrease | 2 Participants |
Primary
Number of Participants With Abnormal Coagulation Laboratory Toxicity Results
Laboratory parameters include prothrombin time (PT), activated partial prothrombin time (PTT), and prothrombin international normalized ratio (INR). Thresholds for adverse events were considered as PT \>= 11.6 s, PTT \>= 30.1 s, INR \>= 1.2. If a coagulation laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Time frame: Baseline (Day -1) through Day 21
Population: Safety Population: All participants that received any amount of study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 40 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 1 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 2 Participants |
| 160 mg Fed | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 1 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 1 Participants |
| Placebo | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin International Normalized Ratio, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Prothrombin Time, Increase | 2 Participants |
| Placebo | Number of Participants With Abnormal Coagulation Laboratory Toxicity Results | Activated Partial Thromboplastin Time, Increase | 2 Participants |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results
Each participant is only counted once per toxicity grade for the worst severity recorded. The only ECG parameter graded was QTcF interval with a threshold of \>= 30 msec. If an ECG value met the threshold for an AE at baseline, subsequent safety ECG results were only considered to be an AE if the grading worsened in severity.
Time frame: Day 1 through Day 21
Population: Safety Population: All participants that received any amount of study product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 40 mg Fasted | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
| Placebo | Number of Participants With Abnormal Electrocardiogram (ECG) Toxicity Results | 0 Participants |
Primary
Number of Participants With Abnormal Hematology Laboratory Toxicity Results
Laboratory parameters and associated thresholds for adverse events include hemoglobin \<= 12.2 g/dL (male) or \<= 10.8 g/dL (female), hematocrit \<= 36.1 % (male) or \<= 32.6 % (female), lymphocyte count \<= 799 cell/mm3, neutrophil count \<= 1,299 cell/mm3 (African Americans) or \<= 1,699 cell/mm3 (all others), monocyte count \>= 1001 cell/mm3, eosinophil count \>= 871 cell/mm3, basophil count \>= 101 cell/mm3, platelet count \<= 150 x 10\^3/mm3, red blood cell (RBC) count \<= 4.1 x 10\^6/uL (male) or \<= 3.7 x 10\^6/uL (female), and white blood cell (WBC) count \>= 9,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Males) or \>= 11,001 cell/mm3 or \<= 2,499 cell/mm3 (African American Females) or \>= 10,001 cell/mm3 or \<= 3,999 cell/mm3 (all others). If a result met the threshold for an AE at baseline, subsequent results were only considered to be an AE if the grading worsened in severity.
Time frame: Baseline (Day -1) through Day 21
Population: Safety Population: All participants that received any amount of study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 1 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Decrease | 1 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Lymphocytes, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Monocytes, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | White Blood Cell, Increase | 1 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hemoglobin, Decrease | 1 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Basophils, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Neutrophils, Decrease | 1 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Red Blood Cell, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Hematocrit, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Platelets, Decrease | 0 Participants |
| Placebo | Number of Participants With Abnormal Hematology Laboratory Toxicity Results | Eosinophils, Increase | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results
The only graded urinalysis laboratory parameter was red blood cells (RBC) by complete urinalysis. The threshold for adverse events was considered as \>=3. If a urinalysis laboratory value met the threshold for an AE at baseline, subsequent safety laboratory results were only considered to be an AE if the grading worsened in severity.
Time frame: Baseline (Day -1) through Day 21
Population: Safety Population: All participants that received any amount of study product with complete urinalysis test performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 40 mg Fasted | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 0 Participants |
| Placebo | Number of Participants With Abnormal Urinalysis Laboratory Toxicity Results | 2 Participants |
Primary
Number of Participants With Abnormal Vital Signs
Each participant is only counted once per toxicity grade for the worst severity recorded. Vital sign parameters include systolic blood pressure (BP), diastolic BP, pulse, respiratory rate, and temperature. Thresholds for abnormal vital signs were considered as systolic BP \>= 141 mmHg or \<= 89 mmHg, diastolic BP \>= 91 mmHg, pulse \<= 54 bpm (baseline \> 60 bpm) or \<=50 (baseline \<= 60 bpm) or \>= 101 bpm, respiratory rate \>= 17 breaths per minute, and temperature \>= 38.0 degrees Celsius. If a vital sign result met the threshold for an AE at baseline, subsequent vital sign results were only considered to be an AE if the grading worsened in severity.
Time frame: Baseline (Day -1) through Day 21
Population: Safety Population: All participants that received any amount of study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 1 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 2 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 0 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 4 Participants |
| 40 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 1 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 5 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 0 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 2 Participants |
| 80 mg Fasted | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 0 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 2 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 5 Participants |
| 160 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 1 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 0 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 2 Participants |
| 160 mg Fed | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 0 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 4 Participants |
| 320 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 0 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 2 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 1 Participants |
| 640 mg Fasted | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Pulse, Decrease | 2 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Pulse, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Respiratory Rate, Increase | 6 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Systolic Blood Pressure, Decrease | 1 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Temperature, Increase | 0 Participants |
| Placebo | Number of Participants With Abnormal Vital Signs | Diastolic Blood Pressure, Increase | 0 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
Adverse events (AEs) are defined as any untoward medical occurrence regardless of its causal relationship to study treatment. Number of participants with an AE are summarized by MedDRA System Organ Class (SOC). Each subject was counted once per SOC. If a condition was present at screening, it was not considered an AE unless the severity worsened.
Time frame: Day 1 through Day 21
Population: Safety Population: All participants that received any amount of study product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 40 mg Fasted | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 0 Participants |
| 40 mg Fasted | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 0 Participants |
| 40 mg Fasted | Number of Participants With Unsolicited Adverse Events | Investigations | 6 Participants |
| 40 mg Fasted | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 0 Participants |
| 40 mg Fasted | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| 40 mg Fasted | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 0 Participants |
| 80 mg Fasted | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 0 Participants |
| 80 mg Fasted | Number of Participants With Unsolicited Adverse Events | Investigations | 6 Participants |
| 80 mg Fasted | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 0 Participants |
| 80 mg Fasted | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 1 Participants |
| 80 mg Fasted | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 0 Participants |
| 80 mg Fasted | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| 160 mg Fasted | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 0 Participants |
| 160 mg Fasted | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| 160 mg Fasted | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 1 Participants |
| 160 mg Fasted | Number of Participants With Unsolicited Adverse Events | Investigations | 6 Participants |
| 160 mg Fasted | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 0 Participants |
| 160 mg Fasted | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 0 Participants |
| 160 mg Fed | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 0 Participants |
| 160 mg Fed | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 0 Participants |
| 160 mg Fed | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 0 Participants |
| 160 mg Fed | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| 160 mg Fed | Number of Participants With Unsolicited Adverse Events | Investigations | 5 Participants |
| 160 mg Fed | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 0 Participants |
| 320 mg Fasted | Number of Participants With Unsolicited Adverse Events | Investigations | 3 Participants |
| 320 mg Fasted | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 0 Participants |
| 320 mg Fasted | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 1 Participants |
| 320 mg Fasted | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 0 Participants |
| 320 mg Fasted | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| 320 mg Fasted | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 0 Participants |
| 640 mg Fasted | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 0 Participants |
| 640 mg Fasted | Number of Participants With Unsolicited Adverse Events | Investigations | 5 Participants |
| 640 mg Fasted | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 0 Participants |
| 640 mg Fasted | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 0 Participants |
| 640 mg Fasted | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 0 Participants |
| 640 mg Fasted | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 0 Participants |
| Placebo | Number of Participants With Unsolicited Adverse Events | Injury, poisoning and procedural complications | 1 Participants |
| Placebo | Number of Participants With Unsolicited Adverse Events | Infections and infestations | 0 Participants |
| Placebo | Number of Participants With Unsolicited Adverse Events | Nervous system disorders | 0 Participants |
| Placebo | Number of Participants With Unsolicited Adverse Events | Investigations | 11 Participants |
| Placebo | Number of Participants With Unsolicited Adverse Events | Musculoskeletal and connective tissue disorders | 0 Participants |
| Placebo | Number of Participants With Unsolicited Adverse Events | General disorders and administration site conditions | 1 Participants |
Secondary
Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the lambda Z (1/h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-11134 | 0.005900 1/h | — |
| 160 mg Fasted | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-11134 | 0.006863 1/h | Standard Deviation 0.001642 |
| 160 mg Fed | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-11134 | 0.005457 1/h | Standard Deviation 0.001711 |
| 320 mg Fasted | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-1598 | 0.01940 1/h | Standard Deviation 0.009617 |
| 320 mg Fasted | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-11134 | 0.005520 1/h | Standard Deviation 0.002165 |
| 640 mg Fasted | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-1598 | 0.06553 1/h | Standard Deviation 0.03096 |
| 640 mg Fasted | Apparent First-order Elimination Rate Constant (Lambda Z) of VT-1598 and VT-11134 | VT-11134 | 0.006034 1/h | Standard Deviation 0.0017 |
Secondary
Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the CL/F (L/h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-11134 | 20.4 L/h | — |
| 160 mg Fasted | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-11134 | 56.6 L/h | Standard Deviation 15.6 |
| 160 mg Fed | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-11134 | 23.5 L/h | Standard Deviation 3.5 |
| 320 mg Fasted | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-1598 | 66.6 L/h | Standard Deviation 32.4 |
| 320 mg Fasted | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-11134 | 51.5 L/h | Standard Deviation 5.65 |
| 640 mg Fasted | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-1598 | 235 L/h | Standard Deviation 43.8 |
| 640 mg Fasted | Apparent Oral Clearance (CL/F) of VT-1598 and VT-11134 | VT-11134 | 90.7 L/h | Standard Deviation 21.8 |
Secondary
Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the Vd/F (L) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-11134 | 3460 L | — |
| 160 mg Fasted | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-11134 | 8230 L | Standard Deviation 1100 |
| 160 mg Fed | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-11134 | 4450 L | Standard Deviation 709 |
| 320 mg Fasted | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-1598 | 3440 L | Standard Deviation 28.3 |
| 320 mg Fasted | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-11134 | 9410 L | Standard Deviation 922 |
| 640 mg Fasted | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-1598 | 4200 L | Standard Deviation 2010 |
| 640 mg Fasted | Apparent Volume of Distribution During Terminal Phase (Vd/F) of VT-1598 and VT-11134 | VT-11134 | 15400 L | Standard Deviation 3820 |
Secondary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the AUC(0-inf) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 1960 h*ng/mL | — |
| 160 mg Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 3005 h*ng/mL | Standard Deviation 875.4 |
| 160 mg Fed | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 6923 h*ng/mL | Standard Deviation 1046 |
| 320 mg Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-1598 | 5445 h*ng/mL | Standard Deviation 2652 |
| 320 mg Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 6260 h*ng/mL | Standard Deviation 703.8 |
| 640 mg Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-1598 | 2797 h*ng/mL | Standard Deviation 515 |
| 640 mg Fasted | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 7506 h*ng/mL | Standard Deviation 2357 |
Secondary
Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the AUC(0-last) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 1233 h*ng/mL | Standard Deviation 500.7 |
| 40 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 214.2 h*ng/mL | Standard Deviation 183.9 |
| 80 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 1551 h*ng/mL | Standard Deviation 628.5 |
| 80 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 894.3 h*ng/mL | Standard Deviation 793.1 |
| 160 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 1540 h*ng/mL | Standard Deviation 2726 |
| 160 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 2560 h*ng/mL | Standard Deviation 857.3 |
| 160 mg Fed | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 6838 h*ng/mL | Standard Deviation 1459 |
| 160 mg Fed | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 6293 h*ng/mL | Standard Deviation 3229 |
| 320 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 5375 h*ng/mL | Standard Deviation 1513 |
| 320 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 4177 h*ng/mL | Standard Deviation 1643 |
| 640 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 7730 h*ng/mL | Standard Deviation 9144 |
| 640 mg Fasted | Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 7342 h*ng/mL | Standard Deviation 1866 |
Secondary
Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last)
Mean and (minimum, maximum) of the amount of VT-1598 and VT-11134 excreted into urine from time zero to the time of the last quantifiable concentration.
Time frame: 0 h through 72 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| 40 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-1598 | 0.0000 mg |
| 40 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-11134 | 0.0000 mg |
| 80 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-1598 | 0.0000 mg |
| 80 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-11134 | 0.0000 mg |
| 160 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-1598 | 0.0000 mg |
| 160 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-11134 | 0.00004167 mg |
| 160 mg Fed | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-1598 | 0.0000 mg |
| 160 mg Fed | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-11134 | 0.0008970 mg |
| 320 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-1598 | 0.0000 mg |
| 320 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-11134 | 0.0000 mg |
| 640 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-1598 | 0.0000 mg |
| 640 mg Fasted | Cumulative Amount of VT-1598 and VT-11134 Excreted Into Urine From Time Zero to the Time of the Last Quantifiable Concentration (Ae Last) | VT-11134 | 0.0002200 mg |
Secondary
Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the dose normalized AUC(0-inf) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 49.00 (h*ng/mL)/mg | — |
| 160 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 18.78 (h*ng/mL)/mg | Standard Deviation 5.471 |
| 160 mg Fed | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 43.27 (h*ng/mL)/mg | Standard Deviation 6.54 |
| 320 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-1598 | 17.02 (h*ng/mL)/mg | Standard Deviation 8.286 |
| 320 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 19.56 (h*ng/mL)/mg | Standard Deviation 2.199 |
| 640 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-1598 | 4.370 (h*ng/mL)/mg | Standard Deviation 0.8047 |
| 640 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to Infinity (AUC(0-inf)) of VT-1598 and VT-11134 | VT-11134 | 11.73 (h*ng/mL)/mg | Standard Deviation 3.683 |
Secondary
Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the dose-normalized AUC(0-last) (h\*ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 30.81 (h*ng/mL)/mg | Standard Deviation 12.52 |
| 40 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 5.354 (h*ng/mL)/mg | Standard Deviation 4.598 |
| 80 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 11.18 (h*ng/mL)/mg | Standard Deviation 9.914 |
| 80 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 19.39 (h*ng/mL)/mg | Standard Deviation 7.856 |
| 160 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 9.623 (h*ng/mL)/mg | Standard Deviation 17.04 |
| 160 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 16.00 (h*ng/mL)/mg | Standard Deviation 5.358 |
| 160 mg Fed | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 42.74 (h*ng/mL)/mg | Standard Deviation 9.117 |
| 160 mg Fed | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 39.33 (h*ng/mL)/mg | Standard Deviation 20.18 |
| 320 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 13.05 (h*ng/mL)/mg | Standard Deviation 5.135 |
| 320 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 16.80 (h*ng/mL)/mg | Standard Deviation 4.727 |
| 640 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-11134 | 11.47 (h*ng/mL)/mg | Standard Deviation 2.916 |
| 640 mg Fasted | Dose-normalized Area Under the Concentration-time Curve From Time Zero to the Last Concentration Above the Lower Limit of Quantification (AUC(0-last)) of VT-1598 and VT-11134 | VT-1598 | 12.08 (h*ng/mL)/mg | Standard Deviation 14.29 |
Secondary
Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the dose-normalized Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-1598 | 0.8858 (ng/mL)/mg | Standard Deviation 0.4492 |
| 40 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-11134 | 0.7513 (ng/mL)/mg | Standard Deviation 0.3368 |
| 80 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-1598 | 0.7992 (ng/mL)/mg | Standard Deviation 0.6298 |
| 80 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-11134 | 0.3564 (ng/mL)/mg | Standard Deviation 0.1737 |
| 160 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-1598 | 0.6756 (ng/mL)/mg | Standard Deviation 0.5973 |
| 160 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-11134 | 0.3189 (ng/mL)/mg | Standard Deviation 0.1568 |
| 160 mg Fed | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-1598 | 2.194 (ng/mL)/mg | Standard Deviation 0.9307 |
| 160 mg Fed | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-11134 | 0.6769 (ng/mL)/mg | Standard Deviation 0.28 |
| 320 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-1598 | 0.6943 (ng/mL)/mg | Standard Deviation 0.3793 |
| 320 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-11134 | 0.2301 (ng/mL)/mg | Standard Deviation 0.1173 |
| 640 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-1598 | 0.5036 (ng/mL)/mg | Standard Deviation 0.2945 |
| 640 mg Fasted | Dose-normalized Maximum Observed Concentration (Cmax/Dose) of VT-1598 and VT-11134 | VT-11134 | 0.1853 (ng/mL)/mg | Standard Deviation 0.08989 |
Secondary
Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the Cmax (ng/mL) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-1598 | 35.43 ng/mL | Standard Deviation 17.97 |
| 40 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-11134 | 30.05 ng/mL | Standard Deviation 13.47 |
| 80 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-1598 | 63.93 ng/mL | Standard Deviation 50.38 |
| 80 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-11134 | 28.51 ng/mL | Standard Deviation 13.89 |
| 160 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-1598 | 108.1 ng/mL | Standard Deviation 95.57 |
| 160 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-11134 | 51.02 ng/mL | Standard Deviation 25.09 |
| 160 mg Fed | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-1598 | 351.0 ng/mL | Standard Deviation 148.9 |
| 160 mg Fed | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-11134 | 108.3 ng/mL | Standard Deviation 44.81 |
| 320 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-1598 | 222.2 ng/mL | Standard Deviation 121.4 |
| 320 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-11134 | 73.63 ng/mL | Standard Deviation 37.55 |
| 640 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-1598 | 322.3 ng/mL | Standard Deviation 188.4 |
| 640 mg Fasted | Maximum Observed Concentration (Cmax) of VT-1598 and VT-11134 | VT-11134 | 118.6 ng/mL | Standard Deviation 57.53 |
Secondary
Percent of VT-1598 Excreted Into Urine (Ae%Dose)
Mean and (minimum, maximum) of the percent of VT-1598 excreted into urine.
Time frame: 0 h through 72 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 40 mg Fasted | Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0.0000 percent |
| 80 mg Fasted | Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0.0000 percent |
| 160 mg Fasted | Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0.0000 percent |
| 160 mg Fed | Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0.0000 percent |
| 320 mg Fasted | Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0.0000 percent |
| 640 mg Fasted | Percent of VT-1598 Excreted Into Urine (Ae%Dose) | 0.0000 percent |
Secondary
Renal Clearance (CLr) of VT-1598 and VT-11134
Mean and standard deviation (SD) of CLr (mL/min) of VT-1598 and VT-11134.
Time frame: 0 h through 72 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-1598 | 0.000 mL/min | Standard Deviation 0 |
| 40 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-11134 | 0.000 mL/min | Standard Deviation 0 |
| 80 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-1598 | 0.000 mL/min | Standard Deviation 0 |
| 80 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-11134 | 0.000 mL/min | Standard Deviation 0 |
| 160 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-1598 | 0.000 mL/min | Standard Deviation 0 |
| 160 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-11134 | 0.000460 mL/min | Standard Deviation 0.00113 |
| 160 mg Fed | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-11134 | 0.00510 mL/min | Standard Deviation 0.00338 |
| 160 mg Fed | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-1598 | 0.000 mL/min | Standard Deviation 0 |
| 320 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-1598 | 0.000 mL/min | Standard Deviation 0 |
| 320 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-11134 | 0.000 mL/min | Standard Deviation 0 |
| 640 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-1598 | 0.000 mL/min | Standard Deviation 0 |
| 640 mg Fasted | Renal Clearance (CLr) of VT-1598 and VT-11134 | VT-11134 | 0.000957 mL/min | Standard Deviation 0.00234 |
Secondary
Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the t 1/2 (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data using Phoenix WinNonlin Non-compartmental Analysis with the following Lambda Z Acceptance Criteria: rsq\_adjusted (adjusted r squared) \>= 0.90, span \>= 2.0 half-lives, and includes at least 3 timepoints after Tmax.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-1598 | 5.403 h | Standard Deviation 3.233 |
| 40 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-11134 | 117.8 h | Standard Deviation 50.49 |
| 80 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-1598 | 29.07 h | Standard Deviation 11.31 |
| 80 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-11134 | 181.7 h | Standard Deviation 127.9 |
| 160 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-1598 | 17.11 h | Standard Deviation 25.09 |
| 160 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-11134 | 158.5 h | Standard Deviation 90.62 |
| 160 mg Fed | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-1598 | 61.38 h | Standard Deviation 54.52 |
| 160 mg Fed | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-11134 | 249.3 h | Standard Deviation 177.2 |
| 320 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-1598 | 40.70 h | Standard Deviation 16.36 |
| 320 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-11134 | 272.0 h | Standard Deviation 174.7 |
| 640 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-1598 | 33.57 h | Standard Deviation 31.79 |
| 640 mg Fasted | Terminal Elimination Half-life (t 1/2) of VT-1598 and VT-11134 | VT-11134 | 210.7 h | Standard Deviation 217.2 |
Secondary
Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134
Mean and standard deviation (SD) of the Tmax (h) PK parameter was estimated from the VT-1598 and VT-11134 plasma concentration-time data.
Time frame: 0 h through 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-1598 | 5.00 h | Standard Deviation 2.68 |
| 40 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-11134 | 5.50 h | Standard Deviation 2.51 |
| 80 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-1598 | 5.00 h | Standard Deviation 1.1 |
| 80 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-11134 | 5.67 h | Standard Deviation 0.818 |
| 160 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-1598 | 4.83 h | Standard Deviation 1.33 |
| 160 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-11134 | 5.17 h | Standard Deviation 1.33 |
| 160 mg Fed | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-1598 | 8.17 h | Standard Deviation 3.49 |
| 160 mg Fed | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-11134 | 7.67 h | Standard Deviation 2.94 |
| 320 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-1598 | 5.05 h | Standard Deviation 1.05 |
| 320 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-11134 | 5.05 h | Standard Deviation 1.05 |
| 640 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-1598 | 4.83 h | Standard Deviation 1.33 |
| 640 mg Fasted | Time of Maximum Observed Concentration (Tmax) of VT-1598 and VT-11134 | VT-11134 | 6.33 h | Standard Deviation 1.97 |
Secondary
VT-11134 Concentrations in Plasma
Mean and standard deviation of VT-11134 concentrations in plasma by nominal time point.
Time frame: 0 h, 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 2 h | 8.763 ng/mL | Standard Deviation 6.556 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 1.5 h | 2.363 ng/mL | Standard Deviation 1.972 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 1 h | 0.185 ng/mL | Standard Deviation 0.453 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 12 h | 13.252 ng/mL | Standard Deviation 4.307 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 60 h | 6.208 ng/mL | Standard Deviation 1.839 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 10 h | 15.968 ng/mL | Standard Deviation 6.143 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 8 h | 16.617 ng/mL | Standard Deviation 6.486 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 72 h | 5.060 ng/mL | Standard Deviation 1.682 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 24 h | 8.815 ng/mL | Standard Deviation 2.712 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 6 h | 25.550 ng/mL | Standard Deviation 11.905 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 144 h | 3.817 ng/mL | Standard Deviation 1.536 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 4 h | 25.748 ng/mL | Standard Deviation 16.413 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 36 h | 6.910 ng/mL | Standard Deviation 1.674 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 312 h | 2.030 ng/mL | Standard Deviation 0.433 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 14 h | 11.377 ng/mL | Standard Deviation 4.804 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 3 h | 21.508 ng/mL | Standard Deviation 14.538 |
| 40 mg Fasted | VT-11134 Concentrations in Plasma | 48 h | 5.872 ng/mL | Standard Deviation 1.676 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 1.5 h | 0.417 ng/mL | Standard Deviation 0.662 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 72 h | 5.580 ng/mL | Standard Deviation 2.248 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 3 h | 9.078 ng/mL | Standard Deviation 8.322 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 6 h | 28.478 ng/mL | Standard Deviation 13.949 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 48 h | 5.875 ng/mL | Standard Deviation 1.974 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 1 h | 0.000 ng/mL | Standard Deviation 0 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 2 h | 1.575 ng/mL | Standard Deviation 1.908 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 4 h | 17.412 ng/mL | Standard Deviation 10.501 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 24 h | 8.382 ng/mL | Standard Deviation 2.757 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 12 h | 16.015 ng/mL | Standard Deviation 8.096 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 312 h | 3.138 ng/mL | Standard Deviation 1.902 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 10 h | 18.990 ng/mL | Standard Deviation 9.337 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 144 h | 3.912 ng/mL | Standard Deviation 1.301 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 60 h | 6.848 ng/mL | Standard Deviation 2.578 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 36 h | 7.332 ng/mL | Standard Deviation 2.52 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 14 h | 12.373 ng/mL | Standard Deviation 5.51 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 8 h | 21.208 ng/mL | Standard Deviation 11.449 |
| 80 mg Fasted | VT-11134 Concentrations in Plasma | 480 h | 2.010 ng/mL | Standard Deviation 0.368 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 3 h | 25.530 ng/mL | Standard Deviation 31.367 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 36 h | 12.468 ng/mL | Standard Deviation 3.626 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 48 h | 10.290 ng/mL | Standard Deviation 3.267 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 60 h | 10.890 ng/mL | Standard Deviation 3.103 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 72 h | 8.773 ng/mL | Standard Deviation 2.048 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 144 h | 6.575 ng/mL | Standard Deviation 2.863 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 312 h | 2.965 ng/mL | Standard Deviation 1.575 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 480 h | 3.010 ng/mL | Standard Deviation 0.636 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 1 h | 1.360 ng/mL | Standard Deviation 2.692 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 1.5 h | 7.052 ng/mL | Standard Deviation 13.11 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 2 h | 13.660 ng/mL | Standard Deviation 23.209 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 4 h | 29.200 ng/mL | Standard Deviation 21.29 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 6 h | 46.750 ng/mL | Standard Deviation 19.144 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 8 h | 35.183 ng/mL | Standard Deviation 15.01 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 10 h | 27.117 ng/mL | Standard Deviation 9.603 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 12 h | 21.950 ng/mL | Standard Deviation 8.474 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 14 h | 19.017 ng/mL | Standard Deviation 5.872 |
| 160 mg Fasted | VT-11134 Concentrations in Plasma | 24 h | 12.680 ng/mL | Standard Deviation 3.804 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 10 h | 86.350 ng/mL | Standard Deviation 40.901 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 48 h | 22.833 ng/mL | Standard Deviation 5.984 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 24 h | 35.450 ng/mL | Standard Deviation 8.349 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 12 h | 79.083 ng/mL | Standard Deviation 29.108 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 3 h | 53.317 ng/mL | Standard Deviation 52.224 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 0.5 h | 0.173 ng/mL | Standard Deviation 0.425 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 144 h | 15.067 ng/mL | Standard Deviation 2.522 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 1 h | 2.320 ng/mL | Standard Deviation 3.618 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 480 h | 5.974 ng/mL | Standard Deviation 3.631 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 14 h | 61.433 ng/mL | Standard Deviation 18.151 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 4 h | 65.700 ng/mL | Standard Deviation 49.461 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 72 h | 18.650 ng/mL | Standard Deviation 4.542 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 36 h | 28.883 ng/mL | Standard Deviation 8.619 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 6 h | 88.200 ng/mL | Standard Deviation 36.162 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 2 h | 25.947 ng/mL | Standard Deviation 33.194 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 312 h | 9.965 ng/mL | Standard Deviation 4.478 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 8 h | 97.317 ng/mL | Standard Deviation 34.864 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 1.5 h | 12.870 ng/mL | Standard Deviation 19.273 |
| 160 mg Fed | VT-11134 Concentrations in Plasma | 60 h | 21.933 ng/mL | Standard Deviation 5.385 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 2 h | 24.652 ng/mL | Standard Deviation 18.888 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 144 h | 11.732 ng/mL | Standard Deviation 3.208 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 48 h | 15.913 ng/mL | Standard Deviation 7.928 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 60 h | 17.750 ng/mL | Standard Deviation 8.877 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 4 h | 67.117 ng/mL | Standard Deviation 40.162 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 14 h | 30.800 ng/mL | Standard Deviation 14.162 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 12 h | 37.167 ng/mL | Standard Deviation 17.016 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 72 h | 17.125 ng/mL | Standard Deviation 5.81 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 3 h | 54.845 ng/mL | Standard Deviation 35.132 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 480 h | 3.982 ng/mL | Standard Deviation 2.234 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 36 h | 22.122 ng/mL | Standard Deviation 9.507 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 10 h | 45.200 ng/mL | Standard Deviation 19.94 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 312 h | 7.183 ng/mL | Standard Deviation 2.189 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 8 h | 52.767 ng/mL | Standard Deviation 24.493 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 24 h | 24.065 ng/mL | Standard Deviation 10.721 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 6 h | 71.200 ng/mL | Standard Deviation 35.14 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 1 h | 2.462 ng/mL | Standard Deviation 3.858 |
| 320 mg Fasted | VT-11134 Concentrations in Plasma | 1.5 h | 10.290 ng/mL | Standard Deviation 9.801 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 48 h | 27.017 ng/mL | Standard Deviation 5.527 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 1.5 h | 18.927 ng/mL | Standard Deviation 12.74 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 312 h | 9.357 ng/mL | Standard Deviation 6.828 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 2 h | 31.732 ng/mL | Standard Deviation 17.109 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 144 h | 17.583 ng/mL | Standard Deviation 5.711 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 3 h | 65.550 ng/mL | Standard Deviation 31.354 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 72 h | 22.550 ng/mL | Standard Deviation 5.99 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 14 h | 45.767 ng/mL | Standard Deviation 17.898 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 4 h | 86.100 ng/mL | Standard Deviation 27.404 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 6 h | 114.817 ng/mL | Standard Deviation 60.895 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 60 h | 26.583 ng/mL | Standard Deviation 4.522 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 8 h | 85.283 ng/mL | Standard Deviation 42.353 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 480 h | 4.122 ng/mL | Standard Deviation 4.557 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 24 h | 34.950 ng/mL | Standard Deviation 7.795 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 10 h | 78.183 ng/mL | Standard Deviation 33.756 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 12 h | 60.850 ng/mL | Standard Deviation 24.612 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 36 h | 31.183 ng/mL | Standard Deviation 8.235 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 640 mg Fasted | VT-11134 Concentrations in Plasma | 1 h | 5.213 ng/mL | Standard Deviation 4.512 |
Secondary
VT-1598 Concentrations in Plasma
Mean and standard deviation of VT-1598 concentrations in plasma by nominal time point.
Time frame: 0 hours (h), 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 24 h, 36 h, 48 h, 60 h, 72 h, 144 h, 312 h, and 480 h post dose
Population: PK Analysis Subset: all participants who received VT-1598 and have at least 1 quantifiable post dose plasma or urine sample with measurable drug or metabolite concentration, as well as no protocol deviations that would likely affect pharmacokinetic (PK) results and who have an evaluable plasma or urine concentration for either VT-1598 or VT-11134 from which at least a subset of the designated PK parameters can be determined.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 2 h | 9.850 ng/mL | Standard Deviation 12.188 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 4 h | 27.180 ng/mL | Standard Deviation 21.812 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 3 h | 20.667 ng/mL | Standard Deviation 20.704 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 24 h | 12.500 ng/mL | — |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 14 h | 19.550 ng/mL | Standard Deviation 7 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 12 h | 24.650 ng/mL | Standard Deviation 12.657 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 1 h | 0.000 ng/mL | Standard Deviation 0 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 10 h | 29.500 ng/mL | Standard Deviation 23.021 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 1.5 h | 4.733 ng/mL | Standard Deviation 7.642 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 8 h | 19.640 ng/mL | Standard Deviation 9.588 |
| 40 mg Fasted | VT-1598 Concentrations in Plasma | 6 h | 26.060 ng/mL | Standard Deviation 12.777 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 48 h | 12.533 ng/mL | Standard Deviation 1.704 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 8 h | 41.983 ng/mL | Standard Deviation 32.838 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 12 h | 40.267 ng/mL | Standard Deviation 19.204 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 4 h | 57.517 ng/mL | Standard Deviation 56.493 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 2 h | 14.633 ng/mL | Standard Deviation 25.117 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 1.5 h | 7.067 ng/mL | Standard Deviation 11.546 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 1 h | 0.000 ng/mL | Standard Deviation 0 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 3 h | 41.400 ng/mL | Standard Deviation 46.9 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 36 h | 16.900 ng/mL | Standard Deviation 3.672 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 60 h | 12.750 ng/mL | Standard Deviation 0.919 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 24 h | 20.200 ng/mL | Standard Deviation 6.92 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 10 h | 42.850 ng/mL | Standard Deviation 25.96 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 14 h | 30.733 ng/mL | Standard Deviation 12.834 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 6 h | 55.283 ng/mL | Standard Deviation 39.53 |
| 80 mg Fasted | VT-1598 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 12 h | 41.160 ng/mL | Standard Deviation 46.266 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 1 h | 6.417 ng/mL | Standard Deviation 9.941 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 1.5 h | 19.317 ng/mL | Standard Deviation 30.014 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 2 h | 35.400 ng/mL | Standard Deviation 51.819 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 3 h | 69.833 ng/mL | Standard Deviation 104.167 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 4 h | 75.600 ng/mL | Standard Deviation 105.466 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 8 h | 64.300 ng/mL | Standard Deviation 62.242 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 10 h | 49.533 ng/mL | Standard Deviation 57.75 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 6 h | 94.133 ng/mL | Standard Deviation 80.855 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 14 h | 45.833 ng/mL | Standard Deviation 46.048 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 24 h | 45.850 ng/mL | Standard Deviation 50.558 |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 36 h | 53.600 ng/mL | — |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 48 h | 48.500 ng/mL | — |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 60 h | 34.900 ng/mL | — |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 72 h | 32.100 ng/mL | — |
| 160 mg Fasted | VT-1598 Concentrations in Plasma | 144 h | 13.800 ng/mL | — |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 8 h | 331.500 ng/mL | Standard Deviation 167.24 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 48 h | 35.720 ng/mL | Standard Deviation 13.997 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 6 h | 269.000 ng/mL | Standard Deviation 108.03 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 144 h | 23.167 ng/mL | Standard Deviation 2.901 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 3 h | 92.717 ng/mL | Standard Deviation 56.432 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 12 h | 213.317 ng/mL | Standard Deviation 107.529 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 2 h | 49.083 ng/mL | Standard Deviation 47.324 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 60 h | 32.500 ng/mL | Standard Deviation 13.927 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 4 h | 119.183 ng/mL | Standard Deviation 24.982 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 1.5 h | 21.100 ng/mL | Standard Deviation 29.765 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 72 h | 34.175 ng/mL | Standard Deviation 8.73 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 14 h | 157.517 ng/mL | Standard Deviation 89.539 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 1 h | 4.333 ng/mL | Standard Deviation 6.78 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 24 h | 68.417 ng/mL | Standard Deviation 34.6 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 10 h | 253.200 ng/mL | Standard Deviation 128.657 |
| 160 mg Fed | VT-1598 Concentrations in Plasma | 36 h | 49.340 ng/mL | Standard Deviation 20.9 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 72 h | 25.860 ng/mL | Standard Deviation 11.428 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 8 h | 128.033 ng/mL | Standard Deviation 46.099 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 6 h | 193.167 ng/mL | Standard Deviation 96.837 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 48 h | 29.333 ng/mL | Standard Deviation 9.868 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 1 h | 8.117 ng/mL | Standard Deviation 12.574 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 144 h | 12.833 ng/mL | Standard Deviation 2.113 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 2 h | 56.550 ng/mL | Standard Deviation 36.542 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 24 h | 38.833 ng/mL | Standard Deviation 12.325 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 60 h | 25.467 ng/mL | Standard Deviation 9.382 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 3 h | 136.850 ng/mL | Standard Deviation 76.482 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 14 h | 54.467 ng/mL | Standard Deviation 12.268 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 36 h | 35.933 ng/mL | Standard Deviation 6.907 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 12 h | 70.817 ng/mL | Standard Deviation 13.916 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 10 h | 98.183 ng/mL | Standard Deviation 40.408 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 4 h | 192.900 ng/mL | Standard Deviation 141.04 |
| 320 mg Fasted | VT-1598 Concentrations in Plasma | 1.5 h | 26.183 ng/mL | Standard Deviation 21.945 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 4 h | 253.817 ng/mL | Standard Deviation 193.963 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 1 h | 18.983 ng/mL | Standard Deviation 24.67 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 8 h | 225.083 ng/mL | Standard Deviation 157.281 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 60 h | 99.667 ng/mL | Standard Deviation 93.713 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 10 h | 184.950 ng/mL | Standard Deviation 138.262 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 0.5 h | 0.000 ng/mL | Standard Deviation 0 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 12 h | 142.133 ng/mL | Standard Deviation 111.611 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 0 h | 0.000 ng/mL | Standard Deviation 0 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 14 h | 105.583 ng/mL | Standard Deviation 85.266 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 24 h | 74.917 ng/mL | Standard Deviation 88.938 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 6 h | 289.000 ng/mL | Standard Deviation 161.294 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 72 h | 114.550 ng/mL | Standard Deviation 77.004 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 36 h | 63.617 ng/mL | Standard Deviation 78.709 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 144 h | 48.300 ng/mL | Standard Deviation 17.112 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 48 h | 76.200 ng/mL | Standard Deviation 89.7 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 2 h | 75.967 ng/mL | Standard Deviation 58.528 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 3 h | 171.700 ng/mL | Standard Deviation 151.63 |
| 640 mg Fasted | VT-1598 Concentrations in Plasma | 1.5 h | 43.617 ng/mL | Standard Deviation 41.759 |