Trial Outcomes & Findings for Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia (NCT NCT01898884)

Last Updated: 2021-06-02

Results Overview

An abnormal laboratory finding which required an action or intervention by the investigator, or a finding judged by the investigator to represent a change beyond the range of normal physiologic fluctuation were reported as an adverse event. Treatment-emergent were events between first dose of study drug and 7 days after the last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with Grade 3 or higher treatment-emergent adverse events for laboratory abnormalities were reported as clinically relevant laboratory changes.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

From Start of Study Treatment up to Day 19

Results posted on

2021-06-02

Participant Flow

This is a multicenter study conducted between 13 August 2013 and 18 June 2015.

A total of 46 participants were enrolled to the study, of which 32 were randomly assigned to single-dose group and 24 were randomly assigned to multiple-dose group. Participants who received investigational product in a single-dose group and completed the post-treatment safety assessment were allowed to enrol in a multiple-dose group.

Participant milestones

Participant milestones
Measure	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Single Dose Placebo Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Single Dose Period STARTED	0	8	6	6	6	6	0	0	0
Single Dose Period COMPLETED	0	8	6	6	6	6	0	0	0
Single Dose Period NOT COMPLETED	0	0	0	0	0	0	0	0	0
Multiple Dose Period STARTED	6	0	0	0	0	0	6	6	6
Multiple Dose Period Treated	5	0	0	0	0	0	6	6	6
Multiple Dose Period COMPLETED	5	0	0	0	0	0	6	5	6
Multiple Dose Period NOT COMPLETED	1	0	0	0	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Single Dose Placebo Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Multiple Dose Period Adverse Event	0	0	0	0	0	0	0	1	0
Multiple Dose Period Randomized Not Treated	1	0	0	0	0	0	0	0	0

Baseline Characteristics

Safety and Pharmacology Study of VP 20629 in Adults With Friedreich's Ataxia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Dose Placebo n=8 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Total n=32 Participants Total of all reporting groups
Age, Continuous	25.1 years STANDARD_DEVIATION 7.04 • n=5 Participants	22.7 years STANDARD_DEVIATION 1.97 • n=7 Participants	27.8 years STANDARD_DEVIATION 4.45 • n=5 Participants	28.0 years STANDARD_DEVIATION 6.90 • n=4 Participants	26.8 years STANDARD_DEVIATION 8.86 • n=21 Participants	26.0 years STANDARD_DEVIATION 6.27 • n=10 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	15 Participants n=10 Participants

PRIMARY outcome

Timeframe: From Start of Study Treatment up to Day 19

Population: The ITT-safety (ITT-S) set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAEs), defined as all AEs that start during study drug treatment (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during study drug treatment (and up to 7 days after the last dose of study drug).

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=8 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo n=6 Participants Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg n=6 Participants Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg n=6 Participants Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg n=5 Participants Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAE	3 participants	0 participants	4 participants	5 participants	6 participants	4 participants	3 participants	6 participants	3 participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAE	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From Start of Study Treatment up to Day 19

Population: The ITT-S set consisted of all participants who were randomly assigned to an investigational product treatment group and who received at least 1 partial or complete dose of investigational product.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=8 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo n=6 Participants Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg n=6 Participants Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg n=6 Participants Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg n=5 Participants Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Blood Glucose Increased	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Number of Participants With Clinically Significant Laboratory Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs) Neutrophil Count Decreased	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants

PRIMARY outcome

Timeframe: From Start of Study Treatment up to Day 19

Vital sign assessments included systolic blood pressure, diastolic blood pressure, heart rate, and temperature. Vital signs abnormalities reported as TEAEs were reported.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=8 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo n=6 Participants Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg n=6 Participants Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg n=6 Participants Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg n=5 Participants Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Number of Participants With Vital Signs Abnormalities Recorded as Treatment-Emergent Adverse Events (TEAEs)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: From Start of Study Treatment up to Day 19

ECG included PR interval, QRS interval, QTcB interval, QTcF interval were considered as clinically significant ECG abnormalities.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=8 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo n=6 Participants Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg n=6 Participants Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg n=6 Participants Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg n=5 Participants Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Number of Participants With Clinically Relevant Electrocardiogram (ECG) Abnormalities Recorded as Adverse Events (AEs)	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" (Number of participants analyzed) and "n" are number of participants analyzed for this outcome measure and for the specified compound, respectively.

The Cmax is the maximum observed plasma concentration of single dose of VP 20629 and VP 20631.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=7 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629 (n=7,6,6,6,6)	269 nanogram per milliliter (ng/mL) Standard Deviation 92	29350 nanogram per milliliter (ng/mL) Standard Deviation 6344	47350 nanogram per milliliter (ng/mL) Standard Deviation 12742	76983 nanogram per milliliter (ng/mL) Standard Deviation 7293	73717 nanogram per milliliter (ng/mL) Standard Deviation 14848	—	—	—	—
Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631 (n=6,6,6,6,6)	7 nanogram per milliliter (ng/mL) Standard Deviation 2	1068 nanogram per milliliter (ng/mL) Standard Deviation 353	3556 nanogram per milliliter (ng/mL) Standard Deviation 2347	12515 nanogram per milliliter (ng/mL) Standard Deviation 6056	15842 nanogram per milliliter (ng/mL) Standard Deviation 12438	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

The Tmax is the time to reach maximum observed plasma concentration of single dose of VP 20629 and VP 20631.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=7 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629 (n=7,6,6,6,6)	9.94 hour Standard Deviation 7.58	1.50 hour Standard Deviation 0.45	1.92 hour Standard Deviation 0.95	1.83 hour Standard Deviation 0.61	3.01 hour Standard Deviation 1.77	—	—	—	—
Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631(n=6,6,6,6,6)	23.71 hour Standard Deviation 20.17	2.17 hour Standard Deviation 0.41	2.83 hour Standard Deviation 2.50	2.16 hour Standard Deviation 0.60	3.35 hour Standard Deviation 2.33	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.

The AUC is the area under the plasma concentration-time curve observed.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631	5118 hournanogram per milliliter (hng/mL) Standard Deviation 1155	14208 hournanogram per milliliter (hng/mL) Standard Deviation 4117	33366 hournanogram per milliliter (hng/mL) Standard Deviation 9374	48322 hournanogram per milliliter (hng/mL) Standard Deviation 17989	—	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629	152277 hournanogram per milliliter (hng/mL) Standard Deviation 27113	298443 hournanogram per milliliter (hng/mL) Standard Deviation 42925	463893 hournanogram per milliliter (hng/mL) Standard Deviation 44896	525976 hournanogram per milliliter (hng/mL) Standard Deviation 107856	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 1

The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=7 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629 (n=7,6,6,6,6)	1708 h*ng/mL Standard Deviation 693	95673 h*ng/mL Standard Deviation 10720	183398 h*ng/mL Standard Deviation 10155	302823 h*ng/mL Standard Deviation 31529	325019 h*ng/mL Standard Deviation 45937	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631 (n=5,6,6,6,6)	21 h*ng/mL Standard Deviation 27	3201 h*ng/mL Standard Deviation 802	9934 h*ng/mL Standard Deviation 4155	27426 h*ng/mL Standard Deviation 8969	37258 h*ng/mL Standard Deviation 19280	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

The AUCt is the measure of the plasma drug concentration from time zero to time t.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=7 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg n=6 Participants Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629 (n=7,6,6,6,6)	9903 h*ng/mL Standard Deviation 4192	147287 h*ng/mL Standard Deviation 25078	294510 h*ng/mL Standard Deviation 41445	457563 h*ng/mL Standard Deviation 46848	519996 h*ng/mL Standard Deviation 106355	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Plasma Concentration (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631 (n=6,6,6,6,6)	164 h*ng/mL Standard Deviation 149	4876 h*ng/mL Standard Deviation 1201	14070 h*ng/mL Standard Deviation 4110	33121 h*ng/mL Standard Deviation 9322	48114 h*ng/mL Standard Deviation 17934	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.

The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629	9.98 hour Interval 8.46 to 13.56	7.87 hour Interval 7.62 to 8.46	7.43 hour Interval 4.4 to 9.44	7.85 hour Interval 6.62 to 8.97	—	—	—	—	—
Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631	11.19 hour Interval 9.14 to 15.09	7.85 hour Interval 7.13 to 8.22	7.72 hour Interval 4.52 to 9.46	6.95 hour Interval 6.29 to 8.52	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.

The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Volume of Distribution (Vz/F) of VP 20629 for Single Dose Groups	15.0 Liter Standard Deviation 3.4	17.6 Liter Standard Deviation 2.9	20.8 Liter Standard Deviation 6.1	26.9 Liter Standard Deviation 6.3	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Total Body Drug Clearance (CL/F) of VP 20629 for Single Dose Groups	1.010 liter per hour Standard Deviation 0.171	1.533 liter per hour Standard Deviation 0.209	1.956 liter per hour Standard Deviation 0.196	2.357 liter per hour Standard Deviation 0.447	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations.

Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=6 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629	0.0688 per hour Standard Deviation 0.0111	0.0874 per hour Standard Deviation 0.0033	0.1007 per hour Standard Deviation 0.0312	0.0892 per hour Standard Deviation 0.0105	—	—	—	—	—
Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631	0.0615 per hour Standard Deviation 0.0114	0.0889 per hour Standard Deviation 0.0046	0.0958 per hour Standard Deviation 0.0295	0.0972 per hour Standard Deviation 0.0124	—	—	—	—	—

SECONDARY outcome

Timeframe: 0-4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The Ae is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=4 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=4 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20629	55.0 microgram (mcg) Standard Deviation 17.2	79.4 microgram (mcg) Standard Deviation 13.3	368.6 microgram (mcg) Standard Deviation 196.3	518.1 microgram (mcg) Standard Deviation 105.6	—	—	—	—	—
Cumulative Amount Excreted Into the Urine (Ae) for Unchanged VP 20629 and Its Metabolite (VP 20631) for Single Dose Groups VP 20631	131644.9 microgram (mcg) Standard Deviation 19834.5	529022.1 microgram (mcg) Standard Deviation 92223.8	953370.1 microgram (mcg) Standard Deviation 116994.6	1263419.7 microgram (mcg) Standard Deviation 190242.9	—	—	—	—	—

SECONDARY outcome

Timeframe: -4, 4-8, 8-16, 16-24, 24-36 and 36-48 hours postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The Ae% is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=4 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=4 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Percentage of Drug Excreted in Urine (Ae%) of VP 20629 for Single Dose Groups	0.0367 percentage of dose Standard Deviation 0.0115	0.0176 percentage of dose Standard Deviation 0.0030	0.0410 percentage of dose Standard Deviation 0.0218	0.0432 percentage of dose Standard Deviation 0.0088	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8,10, 12, 24 and 48 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The CLR is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 1 or Ae(0-24)/AUC(0-24) on Day 1.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=4 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=4 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Renal Clearance (CLR) of VP 20629 for Single Dose Groups	0.0003 liter per hour Standard Deviation 0.0001	0.0003 liter per hour Standard Deviation 0.0001	0.0008 liter per hour Standard Deviation 0.0005	0.0010 liter per hour Standard Deviation 0.0002	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1

The Cmax is the maximum observed plasma concentration of Multiple Dose of VP 20629 and VP 20631.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631 (n=1,6,6,5)	6 nanogram per milliliter (ng/mL) Standard Deviation NA Standard deviation was not evaluable as only 1 participant was analyzed.	556 nanogram per milliliter (ng/mL) Standard Deviation 88	1270 nanogram per milliliter (ng/mL) Standard Deviation 446	2094 nanogram per milliliter (ng/mL) Standard Deviation 480	—	—	—	—	—
Maximum Observed Serum Concentration (Cmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629 (n=6,6,6,5)	172 nanogram per milliliter (ng/mL) Standard Deviation 82	21667 nanogram per milliliter (ng/mL) Standard Deviation 2890	30000 nanogram per milliliter (ng/mL) Standard Deviation 5592	40440 nanogram per milliliter (ng/mL) Standard Deviation 8878	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

The Cmax,ss is the maximum observed plasma concentration at steady state.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629 (n=6,5,6,5)	212 ng/mL Standard Deviation 54	25060 ng/mL Standard Deviation 10656	32583 ng/mL Standard Deviation 6941	45000 ng/mL Standard Deviation 3431	—	—	—	—	—
Maximum Observed Serum Concentration at Steady State (Cmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631 (n=4,5,6,5)	5 ng/mL Standard Deviation 3	754 ng/mL Standard Deviation 194	1638 ng/mL Standard Deviation 252	3156 ng/mL Standard Deviation 1305	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 24 and 72 hours Postdose on Day 1

The Tmax is the time to reach maximum observed plasma concentration of multiple dose of VP 20629 and VP 20631.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629 (n=6,6,6,5)	3.24 hour Standard Deviation 1.72	1.09 hour Standard Deviation 0.38	1.42 hour Standard Deviation 0.38	1.63 hour Standard Deviation 0.71	—	—	—	—	—
Time of Maximum Observed Plasma Concentration (Tmax) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631 (n=1,6,6,5)	0.58 hour Standard Deviation NA Standard deviation was not evaluable as only 1 participant was analyzed.	1.42 hour Standard Deviation 0.49	1.59 hour Standard Deviation 0.38	2.02 hour Standard Deviation 0.82	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

The Tmax,ss is the time to reach maximum observed plasma concentration at steady state of multiple dose of VP 20629 and VP 20631.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=5 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629 (n=6,5,6,5)	6.65 hour Standard Deviation 3.96	0.97 hour Standard Deviation 0.04	2.00 hour Standard Deviation 0.32	1.80 hour Standard Deviation 0.91	—	—	—	—	—
Time of Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631 (n=4,5,6,5)	0.50 hour Standard Deviation 0.71	1.67 hour Standard Deviation 0.42	2.26 hour Standard Deviation 0.53	1.90 hour Standard Deviation 0.89	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The AUC is the area under the plasma concentration-time curve observed.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629	184407 h*ng/ml Standard Deviation 108180	217115 h*ng/ml Standard Deviation 58417	332140 h*ng/ml Standard Deviation 73876	—	—	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve (AUC) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631	5156 h*ng/ml Standard Deviation 1869	9299 h*ng/ml Standard Deviation 2402	14807 h*ng/ml Standard Deviation 2206	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, and 8 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The AUCss is the area under the plasma concentration time curve observed during a dosing at steady state.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629	99794 h*ng/ml Standard Deviation 44105	138567 h*ng/ml Standard Deviation 37102	196587 h*ng/ml Standard Deviation 18647	—	—	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631	2848 h*ng/ml Standard Deviation 677	6006 h*ng/ml Standard Deviation 1215	9732 h*ng/ml Standard Deviation 1932	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6 and 8 hours Postdose on Day 1

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "n" is number of participants analyzed for this outcome measure at given time points.

The AUC(0-8) is the area under the plasma concentration-time curve from time zero to 8 hours postdose.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629 (n=6,6,6,5)	1080 h*ng/mL Standard Deviation 451	72054 h*ng/mL Standard Deviation 21395	113510 h*ng/mL Standard Deviation 26091	144059 h*ng/mL Standard Deviation 10302	—	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve (AUC[0-8]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631 (n=1,6,6,5)	20 h*ng/mL Standard Deviation NA Standard deviation was not evaluable as only 1 participant was analyzed.	1926 h*ng/mL Standard Deviation 315	4130 h*ng/mL Standard Deviation 1137	5740 h*ng/mL Standard Deviation 1076	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

The AUCtau is the measure of the plasma drug concentration from time zero to time t.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=6 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=5 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=6 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg n=5 Participants Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629 (n=6,5,6,5)	6769 h*ng/mL Standard Deviation 1480	177487 h*ng/mL Standard Deviation 102429	212568 h*ng/mL Standard Deviation 57087	325464 h*ng/mL Standard Deviation 72038	—	—	—	—	—
Area Under the Plasma Concentration Versus Time Curve (AUCt) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631 (n=4,5,6,5)	81 h*ng/mL Standard Deviation 124	4992 h*ng/mL Standard Deviation 1790	9103 h*ng/mL Standard Deviation 2358	14570 h*ng/mL Standard Deviation 2177	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629	9.95 hour Standard Deviation 1.09	9.07 hour Standard Deviation 1.21	9.05 hour Standard Deviation 1.18	—	—	—	—	—	—
Terminal Plasma Half-Life (t1/2) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631	10.01 hour Standard Deviation 0.44	9.68 hour Standard Deviation 1.45	9.11 hour Standard Deviation 0.96	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Volume of Distribution (Vz/F) of VP 20629 for Multiple Dose Groups	16.05 liter Standard Deviation 5.28	19.77 liter Standard Deviation 4.62	20.03 liter Standard Deviation 2.98	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Total Body Drug Clearance at Steady State (CLss/F) of VP 20629 for Multiple Dose Groups	1.133 liter per hour Standard Deviation 0.388	1.524 liter per hour Standard Deviation 0.364	1.537 liter per hour Standard Deviation 0.140	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=6 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=5 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631	0.0693 per hour Standard Deviation 0.0031	0.0729 per hour Standard Deviation 0.0107	0.0768 per hour Standard Deviation 0.0085	—	—	—	—	—	—
Elimination Rate Constant (Lambda[z]) of VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629	0.0703 per hour Standard Deviation 0.0076	0.0775 per hour Standard Deviation 0.0094	0.0777 per hour Standard Deviation 0.0111	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The Ae,ss is the amount of drug excreted in urine. It is calculated by multiplying the urinary volume with the urinary drug concentration.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=4 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=4 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20629	56.8 microgram Standard Deviation 48.1	111.4 microgram Standard Deviation 27.5	244.3 microgram Standard Deviation 226.6	—	—	—	—	—	—
Cumulative Amount Excreted Into the Urine at Steady State (Ae,ss) of Unchanged VP 20629 and Its Metabolite (VP 20631) for Multiple Dose Groups VP 20631	110042 microgram Standard Deviation 10852	254540 microgram Standard Deviation 52440	283873 microgram Standard Deviation 78764	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 0-4, 4-8, 8-16, 16-24, 24-36, and 36-48 hours postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The Ae%,ss is the percentage of drug dose excreted into the urine calculated as (Ae divided by dose)∗100.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=4 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=4 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Percentage of Drug Excreted in Urine at Steady-State (Ae%,ss) of VP 20629 for Multiple Dose Groups	0.0568 percentage of dose Standard Deviation 0.0481	0.0557 percentage of dose Standard Deviation 0.0138	0.0814 percentage of dose Standard Deviation 0.0755	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 and 48 hours Postdose on Day 8

Population: The pharmacokinetic set consisted of participants who had quantifiable VP 20629 plasma concentrations. Here, "N" is number of participants analyzed for this outcome measure.

The CLR,ss is the renal clearance of the drug, calculated as Ae/AUC(0-infinity) on Day 8.

Outcome measures

Outcome measures
Measure	Single Dose Placebo n=5 Participants Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.	Single Dose VP 20629 150 mg n=4 Participants Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.	Single Dose VP 20629 450 mg n=4 Participants Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.	Single Dose VP 20629 900 mg Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.	Single Dose VP 20629 1200 mg Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.	Multiple Dose Placebo Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300 mg Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600 mg Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900 mg Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Renal Clearance at Steady State (CLR,ss) of VP 20629 for Multiple Dose Groups	0.0005 liter per hour Standard Deviation 0.0002	0.0009 liter per hour Standard Deviation 0.0004	0.0013 liter per hour Standard Deviation 0.0013	—	—	—	—	—	—

Adverse Events

Single Dose Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Single Dose VP 20629 150mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Dose VP 20629 450mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Single Dose VP 20629 900mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Single Dose VP 20629 1200mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Multiple Dose Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Multiple Dose VP 20629 300mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Multiple Dose VP 20629 600mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Multiple Dose VP 20629 900mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Dose Placebo n=8 participants at risk Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.	Single Dose VP 20629 150mg n=6 participants at risk Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.	Single Dose VP 20629 450mg n=6 participants at risk Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.	Single Dose VP 20629 900mg n=6 participants at risk Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.	Single Dose VP 20629 1200mg n=6 participants at risk Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.	Multiple Dose Placebo n=6 participants at risk Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300mg n=6 participants at risk Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600mg n=6 participants at risk Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900mg n=5 participants at risk Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Cardiac disorders Angina pectoris	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.

Other adverse events

Other adverse events
Measure	Single Dose Placebo n=8 participants at risk Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.	Single Dose VP 20629 150mg n=6 participants at risk Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.	Single Dose VP 20629 450mg n=6 participants at risk Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.	Single Dose VP 20629 900mg n=6 participants at risk Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.	Single Dose VP 20629 1200mg n=6 participants at risk Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.	Multiple Dose Placebo n=6 participants at risk Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 300mg n=6 participants at risk Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 600mg n=6 participants at risk Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.	Multiple Dose VP 20629 900mg n=5 participants at risk Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Cardiac disorders Angina pectoris	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 2 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Cardiac disorders Cardiac discomfort	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Cardiac disorders Palpitations	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Eye disorders Vision blurred	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Flatulence	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Nausea	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Gastrointestinal disorders Vomiting	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
General disorders Chest pain	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
General disorders Fatigue	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	33.3% 2/6 • Number of events 2 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
General disorders Infusion site pain	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
General disorders Local swelling	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
General disorders Pyrexia	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Infections and infestations Cellulitis	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Infections and infestations Skin infection	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Injury, poisoning and procedural complications Laceration	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Injury, poisoning and procedural complications Sunburn	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Investigations Blood glucose increased	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Investigations Electrocardiogram qt prolonged	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Investigations Neutrophil count decreased	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Nervous system disorders Balance disorder	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	50.0% 3/6 • Number of events 3 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	20.0% 1/5 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	50.0% 3/6 • Number of events 3 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	33.3% 2/6 • Number of events 2 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 2 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Nervous system disorders Motor dysfunction	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Nervous system disorders Somnolence	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Psychiatric disorders Insomnia	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Psychiatric disorders Nightmare	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Renal and urinary disorders Urinary incontinence	12.5% 1/8 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Blister	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 2 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	20.0% 1/5 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/5 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.
Vascular disorders Hypertension	0.00% 0/8 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	16.7% 1/6 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	0.00% 0/6 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.	20.0% 1/5 • Number of events 1 • From the start of the study drug administration upto 30 days after the last dose of study drug administration.

Additional Information

Study Director

Shire

Phone: +1 866 842 5335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution may publish results generated from the site individually.
Publication restrictions are in place

Restriction type: OTHER