Trial Outcomes & Findings for A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants (NCT NCT04075409)
NCT ID: NCT04075409
Last Updated: 2021-07-08
Results Overview
Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)
Results posted on
2021-07-08
Participant Flow
The study started to enroll patients in September 2019 and concluded in December 2019.
Participant flow refers to the Safety Set.
Participant milestones
| Measure |
Extensive Metabolizers
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of padsevonil (PSL) 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg twice a day (BID) on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
|
Intermediate Metabolizers
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
|
Poor Metabolizers
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test the Safety, and Tolerability of Padsevonil in Healthy Male Japanese Study Participants
Baseline characteristics by cohort
| Measure |
Extensive Metabolizers
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of padsevonil (PSL) 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg twice a day (BID) on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
|
Intermediate Metabolizers
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
|
Poor Metabolizers
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally.
|
Total Title
n=39 Participants
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 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
|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
32.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
30.9 years
STANDARD_DEVIATION 7.0 • n=4 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
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)Population: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil
|
1029 ng/mL
Interval 832.5 to 1272.0
|
833.6 ng/mL
Interval 674.6 to 1030.0
|
721.3 ng/mL
Interval 583.6 to 891.4
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)Population: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter
AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil
|
5988 h*ng/mL
Interval 4976.0 to 7206.0
|
4645 h*ng/mL
Interval 3860.0 to 5589.0
|
2823 h*ng/mL
Interval 2346.0 to 3397.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)Population: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter
AUC is the area under the plasma concentration-time curve from time zero to infinity.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil
|
6024 h*ng/mL
Interval 5009.0 to 7245.0
|
4666 h*ng/mL
Interval 3879.0 to 5611.0
|
2837 h*ng/mL
Interval 2359.0 to 3412.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)Population: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The t1/2 is the apparent terminal half-life. Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged).
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of a Single Dose Padsevonil
|
5.018 hours
Geometric Coefficient of Variation 22.2
|
5.904 hours
Geometric Coefficient of Variation 21.3
|
6.138 hours
Geometric Coefficient of Variation 24.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3)Population: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The tmax is the time to reach maximum plasma concentration.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil
|
2.000 hours
Interval 0.5 to 4.0
|
3.000 hours
Interval 1.0 to 6.0
|
3.000 hours
Interval 0.5 to 3.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dosePopulation: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss)
|
1375 ng/mL
Interval 1154.0 to 1639.0
|
1318 ng/mL
Interval 1106.0 to 1570.0
|
1263 ng/mL
Interval 1060.0 to 1505.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dosePopulation: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
AUCtau is the area under the plasma concentration time curve over a dosing interval.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil
|
6482 h*ng/mL
Interval 5435.0 to 7730.0
|
6488 h*ng/mL
Interval 5441.0 to 7737.0
|
4824 h*ng/mL
Interval 4045.0 to 5753.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dosePopulation: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The t1/2 is the apparent terminal half-life.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=8 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=2 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=1 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of Multiple Doses Padsevonil
|
NA hours
Geometric Coefficient of Variation NA
Half-life values could not be estimated for more than one third of the participants due to at least one of the reasons (data points \< 3, Lambda\_z interval \< 2x half-life, or Adjusted R\^2 \< 0.8).
|
NA hours
Geometric Coefficient of Variation NA
Half-life values could not be estimated for more than one third of the participants due to at least one of the reasons (data points \< 3, Lambda\_z interval \< 2x half-life, or Adjusted R\^2 \< 0.8).
|
NA hours
Geometric Coefficient of Variation NA
Half-life values could not be estimated for more than one third of the participants due to at least one of the reasons (data points \< 3, Lambda\_z interval \< 2x half-life, or Adjusted R\^2 \< 0.8).
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dosePopulation: The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter.
The tmax, ss is the time of observed maximum plasma concentration at a steady-state.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss)
|
1.500 hours
Interval 0.5 to 4.0
|
2.000 hours
Interval 1.0 to 4.0
|
1.500 hours
Interval 0.5 to 3.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline until the Safety Follow-up Visit (up to Day 21)Population: The Safety Set (SS) consisted of all study participants who had received at least 1 dose of padsevonil.
An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Outcome measures
| Measure |
Poor Metabolizers (PK-PPS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Intermediate Metabolizers (PK-PPS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers (PK-PPS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS).
|
Extensive Metabolizers Multiple Dose (SS)
n=13 Participants
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
n=13 Participants
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
n=13 Participants
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events During the Study
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
Adverse Events
Extensive Metabolizers Single Dose (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Intermediate Metabolizers Single Dose (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Poor Metabolizers Single Dose (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Extensive Metabolizers Multiple Dose (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Intermediate Metabolizers Multiple Dose (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Poor Metabolizers Multiple Dose (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extensive Metabolizers Single Dose (SS)
n=13 participants at risk
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Single Dose (SS)
n=13 participants at risk
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Single Dose (SS)
n=13 participants at risk
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS).
|
Extensive Metabolizers Multiple Dose (SS)
n=13 participants at risk
Extensive metabolizers (Participants confirmed with genotype \*1/\*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Intermediate Metabolizers Multiple Dose (SS)
n=13 participants at risk
Intermediate metabolizers (Participants confirmed with genotype \*1/\*2,\*1/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
Poor Metabolizers Multiple Dose (SS)
n=13 participants at risk
Poor metabolizers (Participants confirmed with genotype \*2/\*2, \*2/\*3, \*3/\*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS).
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Nervous system disorders
Somnolence
|
100.0%
13/13 • Number of events 13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
100.0%
13/13 • Number of events 13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
100.0%
13/13 • Number of events 14 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
100.0%
13/13 • Number of events 73 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
100.0%
13/13 • Number of events 78 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
100.0%
13/13 • Number of events 84 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Nervous system disorders
Dizziness
|
46.2%
6/13 • Number of events 6 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
69.2%
9/13 • Number of events 9 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
61.5%
8/13 • Number of events 9 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
53.8%
7/13 • Number of events 23 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
61.5%
8/13 • Number of events 28 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
61.5%
8/13 • Number of events 29 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
38.5%
5/13 • Number of events 7 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
23.1%
3/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Nervous system disorders
Dizziness postural
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
15.4%
2/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
23.1%
3/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 3 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 2 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
7.7%
1/13 • Number of events 1 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
0.00%
0/13 • Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60