Trial Outcomes & Findings for A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects (NCT NCT02415439)
NCT ID: NCT02415439
Last Updated: 2017-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
86 participants
Primary outcome timeframe
Participants will be followed for the duration of hospital stay of 4 days
Results posted on
2017-03-10
Participant Flow
In the single ascending dose (SAD) study, subjects were assigned to 1 of 7 dose groups and received a single oral dose of VBP15 or placebo. The multiple ascending dose (MAD) was initiated after a review of safety data from SAD groups. In the MAD study, subjects were randomized to 1 of 4 groups to receive VBP15 or placebo once daily for 14 days
An escalating-dose design was chosen for the SAD and MAD studies to allow increase of the dose after assessment of safety and tolerability of each preceding dose. Escalation to the next higher dose was performed using a factor of 3 for each subsequent dose until a maximum of 20 mg/kg was reached. No subject received more than 1 dose level of VBP15.
Participant milestones
| Measure |
VBP15- 0.1 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasted SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
|
Placebo SAD
Subjects were orally administered a single dose of placebo under fasted conditions.
|
VBP15- 1.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
|
VBP15- 3.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
|
VBP15- 9.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
|
VBP15- 20 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
|
Placebo MAD
Subjects were orally administered placebo daily for 14 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
12
|
5
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions
|
VBP15- 8.0 mg/kg Fasted SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions
|
VBP15- 8.0 mg/kg Fed SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal
|
VBP15- 20.0 mg/kg SAD
n=6 Participants
Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions
|
Placebo SAD
n=12 Participants
Subjects were orally administered a single dose of placebo under fasted conditions
|
VBP15- 1.0 mg/kg 14 Days MAD
n=6 Participants
Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions
|
VBP15 - 3.0 mg/kg 14 Days MAD
n=6 Participants
Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions
|
VBP15- 9.0 mg/kg 14 Days MAD
n=6 Participants
Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions
|
VBP15- 20.0 mg/kg 14 Days MAD
n=6 Participants
Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions
|
Placebo MAD
n=8 Participants
Subjects were orally administered placebo daily for 14 days under fasted conditions
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=22 Participants
|
86 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=22 Participants
|
86 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
6 participants
n=115 Participants
|
12 participants
n=6 Participants
|
6 participants
n=6 Participants
|
6 participants
n=64 Participants
|
6 participants
n=17 Participants
|
6 participants
n=21 Participants
|
8 participants
n=22 Participants
|
86 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay of 4 daysOutcome measures
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasting SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
n=12 Participants
Subjects were administered a single dose of placebo under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Effects After a Single Dose of VBP15
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay of 4 daysOutcome measures
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasting SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
n=12 Participants
Subjects were administered a single dose of placebo under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)
|
42 (hr*ng/mL)
Standard Deviation 17
|
161 (hr*ng/mL)
Standard Deviation 16
|
486 (hr*ng/mL)
Standard Deviation 20
|
1578 (hr*ng/mL)
Standard Deviation 21
|
3997 (hr*ng/mL)
Standard Deviation 55
|
10139 (hr*ng/mL)
Standard Deviation 25
|
8545 (hr*ng/mL)
Standard Deviation 30
|
0 (hr*ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay of 4 daysOutcome measures
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasting SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
n=12 Participants
Subjects were administered a single dose of placebo under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15
|
13 (ng/mL)
Standard Deviation 13
|
51 (ng/mL)
Standard Deviation 17
|
122 (ng/mL)
Standard Deviation 33
|
305 (ng/mL)
Standard Deviation 24
|
718 (ng/mL)
Standard Deviation 43
|
1817 (ng/mL)
Standard Deviation 31
|
1648 (ng/mL)
Standard Deviation 17
|
0 (ng/mL)
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay of 15 daysOutcome measures
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasting SAD
n=8 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
Subjects were administered a single dose of placebo under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay of 15 daysOutcome measures
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasting SAD
n=12 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
Subjects were administered a single dose of placebo under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)
|
794 (hr*ng/mL)
Standard Deviation 22
|
1494 (hr*ng/mL)
Standard Deviation 19
|
4366 (hr*ng/mL)
Standard Deviation 20
|
9309 (hr*ng/mL)
Standard Deviation 39
|
0 (hr*ng/mL)
Standard Deviation 0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Participants will be followed for the duration of hospital stay of 15 daysOutcome measures
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 Participants
Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 Participants
Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasting SAD
n=8 Participants
Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
Subjects were administered a single dose of placebo under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|
|
Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15
|
153 (ng/mL)
Standard Deviation 16
|
281 (ng/mL)
Standard Deviation 37
|
1082 (ng/mL)
Standard Deviation 23
|
2416 (ng/mL)
Standard Deviation 51
|
0 (ng/mL)
Standard Deviation 0
|
—
|
—
|
—
|
Adverse Events
VBP15- 0.1 mg/kg SAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VBP15- 0.3 mg/kg SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VBP15- 1.0 mg/kg SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VBP15- 3.0 mg/kg SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VBP15- 8.0 mg/kg Fasted SAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VBP15- 8.0 mg/kg Fed SAD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
VBP15- 20.0 mg/kg SAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo SAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VBP15- 1.0 mg/kg 14 Days MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VBP15- 3.0 mg/kg 14 Days MAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VBP15- 9.0 mg/kg 14 Days MAD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VBP15- 20.0 mg/kg 14 Days MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo MAD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VBP15- 0.1 mg/kg SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
|
VBP15- 0.3 mg/kg SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
VBP15- 1.0 mg/kg SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
|
VBP15- 3.0 mg/kg SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fasted SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
|
VBP15- 8.0 mg/kg Fed SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
|
VBP15- 20.0 mg/kg SAD
n=6 participants at risk
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
|
Placebo SAD
n=12 participants at risk
Subjects were orally administered a single dose of placebo under fasted conditions.
|
VBP15- 1.0 mg/kg 14 Days MAD
n=6 participants at risk
Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
|
VBP15- 3.0 mg/kg 14 Days MAD
n=6 participants at risk
Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
|
VBP15- 9.0 mg/kg 14 Days MAD
n=6 participants at risk
Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
|
VBP15- 20.0 mg/kg 14 Days MAD
n=6 participants at risk
Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
|
Placebo MAD
n=8 participants at risk
Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
|
Ear and labyrinth disorders
Ear Pain, Left
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Investigations
Blood bilirubin, increased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain extremity left elbow
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Nervous system disorders
Syncope
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/8
|
|
Investigations
Elevated liver enzymes
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Worsening of toothache-right upper molar
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Elevated liver enzyme: ALT
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/12
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60