Trial Outcomes & Findings for A First-in-Human Study of SBP-9330 in Healthy Subjects (NCT NCT04948827)
NCT ID: NCT04948827
Last Updated: 2024-04-16
Results Overview
Number of drug-related adverse events as determined by clinically significant changes in vital signs, physical examination findings, ECG parameters, C-SSRS questionnaire results, and clinical laboratory results
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
90 participants
Primary outcome timeframe
Part A: 8 days Part B: 21 days Part C: 21 days
Results posted on
2024-04-16
Participant Flow
Participant milestones
| Measure |
Part A1 Single Dose (Active; 150 mg)
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A3 - Single-Dose Food-Effect (Active; 225 mg)
In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A2 - Single-Dose (Active; 300 mg)
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A4 - Single-Dose (Active; 450 mg)
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A5 - Single-Dose (Active; 600 mg)
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A - Single Dose - Placebo (Pooled)
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part B1 - Multiple-Dose (Active; 150 mg)
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part B2 - Multiple-Dose (Active; 225 mg)
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part B3 - Multiple-Dose (Active; 300 mg)
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part B - Multiple-Dose Placebo (Pooled)
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C1 - Smoker Phase (Active; 150 mg)
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C2 - Smoker Phase (Active; 225 mg)
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C - Smoker Phase Placebo (Pooled)
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
10
|
8
|
8
|
8
|
6
|
8
|
8
|
4
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
6
|
10
|
7
|
6
|
8
|
6
|
6
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First-in-Human Study of SBP-9330 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part A1 - Single-Dose (Active; 150 mg )
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
SBP-9330: SBP-9330 oral capsules
|
Part A2 - Single-Dose Food-Effect (Active; 225 mg)
n=6 Participants
In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
SBP-9330: SBP-9330 oral capsules
|
Part A3 - Single-Dose (Active; 300 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
SBP-9330: SBP-9330 oral capsules
|
Part A4 - Single-Dose (Active; 450 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
SBP-9330: SBP-9330 oral capsules
|
Part A5 - Single-Dose (Active; 600 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
SBP-9330: SBP-9330 oral capsules
|
Part A - Single Dose - Placebo (Pooled)
n=10 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
Placebo: Placebo oral capsules
|
Part B1 - Multiple-Dose (Active; 150 mg)
n=8 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
SBP-9330: SBP-9330 oral capsules
|
Part B2 - Multiple-Dose (Active; 225 mg)
n=8 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
SBP-9330: SBP-9330 oral capsules
|
Part B3 - Multiple-Dose (Active; 300 mg)
n=8 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
SBP-9330: SBP-9330 oral capsules
|
Part B - Multiple-Dose Placebo (Pooled)
n=6 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Placebo: Placebo oral capsules
|
Part C1 - Smoker Phase (Active; 150 mg)
n=8 Participants
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
SBP-9330: SBP-9330 oral capsules
|
Part C2 - Smoker Phase (Active; 225 mg)
n=8 Participants
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
SBP-9330: SBP-9330 oral capsules
|
Part C - Smoker Phase Placebo (Pooled)
n=4 Participants
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
Placebo: Placebo oral capsules
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 12.26 • n=99 Participants
|
38.5 years
STANDARD_DEVIATION 10.09 • n=107 Participants
|
35.3 years
STANDARD_DEVIATION 7.12 • n=206 Participants
|
33.8 years
STANDARD_DEVIATION 9.41 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 9.24 • n=31 Participants
|
37.7 years
STANDARD_DEVIATION 11.44 • n=30 Participants
|
34.0 years
STANDARD_DEVIATION 8.83 • n=3 Participants
|
36.0 years
STANDARD_DEVIATION 8.57 • n=6 Participants
|
38.5 years
STANDARD_DEVIATION 9.23 • n=114 Participants
|
32.8 years
STANDARD_DEVIATION 11.69
|
40.3 years
STANDARD_DEVIATION 7.52 • n=19 Participants
|
44.0 years
STANDARD_DEVIATION 8.28 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 9.74 • n=7 Participants
|
36.0 years
STANDARD_DEVIATION 9.24 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
36 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
6 Participants
|
6 Participants
n=19 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
54 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
8 Participants
n=114 Participants
|
5 Participants
|
8 Participants
n=19 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
79 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
3 Participants
|
3 Participants
n=19 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
38 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
3 Participants
|
2 Participants
n=19 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
45 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
10 participants
n=30 Participants
|
8 participants
n=3 Participants
|
8 participants
n=6 Participants
|
8 participants
n=114 Participants
|
6 participants
|
8 participants
n=19 Participants
|
8 participants
n=4 Participants
|
4 participants
n=7 Participants
|
90 participants
n=7 Participants
|
|
Body mass index
|
26.02 kg/m^2
STANDARD_DEVIATION 4.005 • n=99 Participants
|
28.70 kg/m^2
STANDARD_DEVIATION 2.021 • n=107 Participants
|
25.47 kg/m^2
STANDARD_DEVIATION 3.755 • n=206 Participants
|
28.97 kg/m^2
STANDARD_DEVIATION 1.783 • n=7 Participants
|
26.65 kg/m^2
STANDARD_DEVIATION 2.643 • n=31 Participants
|
26.20 kg/m^2
STANDARD_DEVIATION 2.363 • n=30 Participants
|
25.86 kg/m^2
STANDARD_DEVIATION 2.529 • n=3 Participants
|
27.38 kg/m^2
STANDARD_DEVIATION 2.604 • n=6 Participants
|
27.83 kg/m^2
STANDARD_DEVIATION 3.290 • n=114 Participants
|
25.13 kg/m^2
STANDARD_DEVIATION 3.197
|
25.34 kg/m^2
STANDARD_DEVIATION 4.489 • n=19 Participants
|
26.98 kg/m^2
STANDARD_DEVIATION 3.475 • n=4 Participants
|
24.05 kg/m^2
STANDARD_DEVIATION 3.884 • n=7 Participants
|
26.2 kg/m^2
STANDARD_DEVIATION 3.197 • n=7 Participants
|
PRIMARY outcome
Timeframe: Part A: 8 days Part B: 21 days Part C: 21 daysNumber of drug-related adverse events as determined by clinically significant changes in vital signs, physical examination findings, ECG parameters, C-SSRS questionnaire results, and clinical laboratory results
Outcome measures
| Measure |
A1 Single Dose (Active; 150 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A2 - Single-Dose Food-Effect (Active; 225 mg)
n=6 Participants
In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A3 - Single-Dose (Active; 300 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A4 - Single-Dose (Active; 450 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A5 - Single-Dose (Active; 600 mg)
n=6 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A - Single Dose - Placebo (Pooled)
n=10 Participants
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part B1 - Multiple-Dose (Active; 150 mg)
n=8 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Active Comparator: Part B2 - Multiple-Dose (Active; 225 mg)
n=8 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Active Comparator: Part B3 - Multiple-Dose (Active; 300 mg)
n=8 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part B - Multiple-Dose Placebo (Pooled)
n=6 Participants
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C1 - Smoker Phase (Active; 150 mg)
n=8 Participants
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C2 - Smoker Phase (Active; 225 mg)
n=8 Participants
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C - Smoker Phase Placebo (Pooled)
n=4 Participants
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events [Safety and Tolerability]
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseMaximum observed concentration (Cmax)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseTime to reach maximum observed concentration (Tmax)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 24 hours post-doseArea under the concentration time curve from time 0 (dose administration) to 24 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseArea under the concentration time curve from time 0 (dose administration) to the time of last quantifiable concentration
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseArea under the concentration time curve extrapolated to infinity
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseTerminal elimination half-life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseApparent total clearance
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseApparent volume of distribution
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseObserved concentration at the end of the dosing interval
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseConcentration at the end of the dosing interval.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseArea under the concentration time curve over the dosing interval at steady state, calculated from 0 to 24 hours (dosing interval)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseEffective half-life
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseApparent total clearance at steady state
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseApparent volume of distribution at steady state
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseAccumulation ratio evaluated by comparing Day 14 Cmax to Day 1 Cmax
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: PK samples were obtained at selected timepoints from pre-dose until 48 hours post-doseAccumulation ratio evaluated by comparing Day 14 AUCτ to Day 1 AUC0-24
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily from Screening through Day 14Expired breath CO was measured with a Bedfont Smokerlyzer™
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Predose, Day 7 and Day 14Blood samples were collected to measure plasma cotinine levels
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Daily from Screening through Day 14A daily smoking log was kept to document the number of cigarettes smoked
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening through Day 14A self-report measure used to monitor symptoms of tobacco withdrawal.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Screening through Day 15A self-report questionnaire used to measure cravings to smoke.
Outcome measures
Outcome data not reported
Adverse Events
A1 Single Dose (Active; 150 mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A3 - Single-Dose Food-Effect (Active; 225 mg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A2 - Single-Dose (Active; 300 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A4 - Single-Dose (Active; 450 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A5 - Single-Dose (Active; 600 mg)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A - Single Dose - Placebo (Pooled)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B1 - Multiple-Dose (Active; 150 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Active Comparator: Part B3 - Multiple-Dose (Active; 225 mg)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Active Comparator: Part B2 - Multiple-Dose (Active; 300 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part B - Multiple-Dose Placebo (Pooled)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part C1 - Smoker Phase (Active; 150 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part C2 - Smoker Phase (Active; 225 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part C - Smoker Phase Placebo (Pooled)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A1 Single Dose (Active; 150 mg)
n=6 participants at risk
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A3 - Single-Dose Food-Effect (Active; 225 mg)
n=6 participants at risk
In this two-period food-effect cohort, each healthy nonsmoker subject received the randomly assigned treatment (SBP-9330 or placebo) under fasting conditions (Period 1). After a 7- to 14-day washout period, subjects received the same single dose of SBP-9330 or placebo in a fed state (Period 2) 30 minutes after the start of an FDA High-Fat and High-Calorie Breakfast. A sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data was completed prior to administration of doses to the remainder of the cohort.
|
Part A2 - Single-Dose (Active; 300 mg)
n=6 participants at risk
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
|
Part A4 - Single-Dose (Active; 450 mg)
n=6 participants at risk
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
|
Part A5 - Single-Dose (Active; 600 mg)
n=6 participants at risk
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
|
Part A - Single Dose - Placebo (Pooled)
n=10 participants at risk
In Part A, cohorts of healthy nonsmokers were randomized to either active SBP-9330 or matching placebo. In each cohort a sentinel group of 2 subjects was randomized and dosed ahead of the rest of the cohort. A review of safety data will be completed prior to administration of doses to the remainder of the cohort.
|
Part B1 - Multiple-Dose (Active; 150 mg)
n=8 participants at risk
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Active Comparator: Part B3 - Multiple-Dose (Active; 225 mg)
n=8 participants at risk
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Active Comparator: Part B2 - Multiple-Dose (Active; 300 mg)
n=8 participants at risk
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part B - Multiple-Dose Placebo (Pooled)
n=6 participants at risk
In Part B, cohorts of healthy nonsmokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C1 - Smoker Phase (Active; 150 mg)
n=8 participants at risk
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C2 - Smoker Phase (Active; 225 mg)
n=8 participants at risk
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
Part C - Smoker Phase Placebo (Pooled)
n=4 participants at risk
In Part C, cohorts of healthy smokers were randomized to receive once daily doses of active SBP-9330 or matching placebo for 14 consecutive days in increasing dose cohorts.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Infections and infestations
Influenza
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
20.0%
2/10 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
10.0%
1/10 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
75.0%
6/8 • Number of events 6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
1/4 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Investigations
Orthostatic heart rate response increased
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Infections and infestations
COVID-19
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
25.0%
2/8 • Number of events 2 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Skin and subcutaneous tissue disorders
Ingrown hair
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
16.7%
1/6 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
|
Nervous system disorders
Paresthesia oral
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/10 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/6 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/8 • Part A: 8 days Part B: 21 days Part C: 21 days
|
12.5%
1/8 • Number of events 1 • Part A: 8 days Part B: 21 days Part C: 21 days
|
0.00%
0/4 • Part A: 8 days Part B: 21 days Part C: 21 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place