Trial Outcomes & Findings for A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function (NCT NCT04136444)
NCT ID: NCT04136444
Last Updated: 2021-07-28
Results Overview
Cmax is maximum observed plasma concentration.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdose
Results posted on
2021-07-28
Participant Flow
The study started to enroll study participants in October 2019 and concluded in May 2020.
Participant Flow refers to the Safety Set (SS).
Participant milestones
| Measure |
Cohort A
Healthy study participants in Cohort A received a single dose of padsevonil 100 milligrams (mg) on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg twice daily (bid) from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
|
Cohort B
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
|
Overall Study
COMPLETED
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort A
Healthy study participants in Cohort A received a single dose of padsevonil 100 milligrams (mg) on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg twice daily (bid) from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
|
Cohort B
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
|
|---|---|---|
|
Overall Study
Sponsor request due to undisclosed concomitant medication
|
0
|
1
|
Baseline Characteristics
A Pharmacokinetic Study of Padsevonil in Study Participants With Either Normal or Moderately Impaired Hepatic Function
Baseline characteristics by cohort
| Measure |
Cohort A
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 milligrams (mg) on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg twice daily (bid) from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
|
Cohort B
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period 1 and 2.
|
Total Title
n=12 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.0 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
57.8 years
STANDARD_DEVIATION 4.3 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdosePopulation: The Pharmacokinetic Set (PKS) is a subset of the Full Analysis Set (FAS), consisting of those study participants who had no important protocol deviations affecting the PK parameters and had a sufficient number of samples available to determine at least 1 PK parameter. All PK analyses were performed using the PKS.
Cmax is maximum observed plasma concentration.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=8 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil (PSL)
|
NA nanograms/milliliter (ng/mL)
As pre-specified in the Protocol/Statistical Analysis Plan, Geometric Means are only calculated if at least 2/3 of the individual data points are above lower limit of quantification (LLOQ).
|
531.4 nanograms/milliliter (ng/mL)
Interval 347.5 to 812.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdosePopulation: The Pharmacokinetic Set (PKS) is a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and had a sufficient number of samples available to determine at least 1 PK parameter. All PK analyses were performed using the PKS.
AUC (0-t) is defined as area under the plasma concentration-time curve from time zero to time t.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=8 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve From Time 0 to t (AUC0-t) of a Single Dose Padsevonil (PSL)
|
NA hours*nanograms per milliliter (h*ng/mL)
As pre-specified in the Protocol/Statistical Analysis Plan, Geometric Means are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
3793 hours*nanograms per milliliter (h*ng/mL)
Interval 1896.0 to 7591.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Plasma samples were taken predose on Day 1 and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 and 96 hours postdosePopulation: The Pharmacokinetic Set (PKS) is a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and had a sufficient number of samples available to determine at least 1 PK parameter. All PK analyses were performed using the PKS.
AUC is defined as area under the plasma concentration-time curve from time 0 to infinity.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=8 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity of a Single Dose Padsevonil (PSL)
|
NA hours*ng/mL
As pre-specified in the Protocol/Statistical Analysis Plan, Geometric Means are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
3830 hours*ng/mL
Interval 1911.0 to 7677.0
|
—
|
—
|
PRIMARY outcome
Timeframe: On Days 8, 9, 10 and 11 PK samples were taken predose. On Day 12, PK samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 5, 6, 8, 12, 24 hours postdosePopulation: The Pharmacokinetic Set (PKS) is a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and had a sufficient number of samples available to determine at least 1 PK parameter. All PK analyses were performed using the PKS.
Cmax,ss is defined as maximum observed plasma concentration at steady-state.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=8 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration at Steady-state (Cmax,ss) of Multiple Doses Padsevonil (PSL)
|
NA nanograms per milliliter (ng/mL)
As pre-specified in the Protocol/Statistical Analysis Plan, Geometric Means are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
558.1 nanograms per milliliter (ng/mL)
Interval 346.9 to 897.8
|
—
|
—
|
PRIMARY outcome
Timeframe: On Days 8, 9, 10 and 11 PK samples were taken predose. On Day 12, PK samples were taken predose and 0.25, 0.5, 0.75, 1, 1.5, 3, 4, 5, 6, 8, 12, 24 hours postdosePopulation: The Pharmacokinetic Set (PKS) is a subset of the FAS, consisting of those study participants who had no important protocol deviations affecting the PK parameters and had a sufficient number of samples available to determine at least 1 PK parameter. All PK analyses were performed using the PKS.
AUCtau is defined as area under the curve over a dosing interval at steady-state.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=8 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve (AUCtau) at Steady-state Over a Dosing Interval of Multiple Doses Padsevonil (PSL)
|
NA hours*ng/mL
As pre-specified in the Protocol/Statistical Analysis Plan, Geometric Means are only calculated if at least 2/3 of the individual data points are above LLOQ.
|
3783 hours*ng/mL
Interval 2260.0 to 6332.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline until End of Study Visit (up to Day 18)Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose of the investigational medicinal product (IMP). Study participants were classified according to the treatment that was actually received. All safety analyses were performed using the SS.
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event was characterized according to the intake of the study medication.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
n=3 Participants
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From Baseline until End of Study Visit (up to Day 18)Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose of the investigational medicinal product (IMP). Study participants were classified according to the treatment that was actually received. All safety analyses were performed using the SS.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
n=3 Participants
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline until End of Study Visit (up to Day 18)Population: The Safety Set (SS) consisted of all study participants who received at least 1 dose of the investigational medicinal product (IMP). Study participants were classified according to the treatment that was actually received. All safety analyses were performed using the SS.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event was characterized according to the intake of the study medication. TEAEs leading to discontinuation of the study are reported.
Outcome measures
| Measure |
Cohort A (PKS)
n=3 Participants
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the Pharmacokinetic Set (PKS).
|
Cohort B (PKS)
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 and multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. There was a Washout Period of 6 days between Treatment Period. Participants formed the PKS.
|
Cohort A Multiple Dose (SS)
n=3 Participants
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
n=9 Participants
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation of the Study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort A Single Dose (SS)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B Single Dose (SS)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A Multiple Dose (SS)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B Multiple Dose (SS)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A Single Dose (SS)
n=3 participants at risk
Healthy study participants in Cohort A received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 as oral tablets. Participants formed the Safety Set (SS).
|
Cohort B Single Dose (SS)
n=9 participants at risk
Participants with moderate hepatic insufficiency in Cohort B received a single dose of padsevonil 100 mg on Day 1 of Treatment Period 1 as oral tablets. Participants formed the SS.
|
Cohort A Multiple Dose (SS)
n=3 participants at risk
Healthy study participants in Cohort A received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
Cohort B Multiple Dose (SS)
n=9 participants at risk
Participants with moderate hepatic insufficiency in Cohort B received multiple doses of padsevonil 100 mg bid from Day 8 to 11 and a single dose of padsevonil 100 mg on Day 12 during Treatment Period 2 as oral tablets. Participants formed the SS.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
44.4%
4/9 • Number of events 4 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Nervous system disorders
Somnolence
|
100.0%
3/3 • Number of events 3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
22.2%
2/9 • Number of events 2 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
100.0%
3/3 • Number of events 3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
33.3%
3/9 • Number of events 3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/9 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
0.00%
0/3 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
11.1%
1/9 • Number of events 1 • Treatment-emergent Adverse Events (AEs) were collected from Baseline until End of Study Visit (up to Day 18)
Treatment-emergent AE was defined as any AE with a start date/time on or after the first dose of study medication or any unresolved event already present before administration of study medication that worsened in intensity following exposure to the treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60