Trial Outcomes & Findings for A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants (NCT NCT04126343)
NCT ID: NCT04126343
Last Updated: 2021-06-18
Results Overview
Placebo-corrected change from Baseline in corrected QT interval (QTc), based on Fridericia's correction (QTcF) method (ΔΔQTcF) evaluated during the Target Dose Day of the padsevonil and placebo Treatment Periods, using linear mixed-effects model analysis.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
54 participants
Primary outcome timeframe
Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdose
Results posted on
2021-06-18
Participant Flow
The study started to enroll study participants in October 2019 and concluded in May 2020.
The Participant Flow refers to the Safety Set.
Participant milestones
| Measure |
Treatment Sequence: ABC
Padsevonil (PSL) Treatment Period (Treatment A)- participants received PSL 100 milligrams (mg) to 400 mg, orally twice daily (bid) during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon.
Placebo Treatment Period (Treatment B)-participants received Placebo matched to PSL Treatment Period doses, bid up to Day 11.
Moxifloxacin (MXF) Treatment Period (Treatment C)- participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon.
Participants received PSL, Placebo, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: ACB
Participants received PSL, MXF, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: BAC
Participants received Placebo, PSL, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: BCA
Participants received Placebo, MXF, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: CAB
Participants received MXF, PSL, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: CBA
Participants received MXF, Placebo, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Overall Study
Completed Padsevonil Period
|
9
|
9
|
9
|
7
|
9
|
8
|
|
Overall Study
Completed Placebo Period
|
9
|
7
|
9
|
9
|
7
|
9
|
|
Overall Study
Completed Moxifloxacin Period
|
8
|
9
|
7
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
5
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
3
|
4
|
3
|
4
|
Reasons for withdrawal
| Measure |
Treatment Sequence: ABC
Padsevonil (PSL) Treatment Period (Treatment A)- participants received PSL 100 milligrams (mg) to 400 mg, orally twice daily (bid) during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon.
Placebo Treatment Period (Treatment B)-participants received Placebo matched to PSL Treatment Period doses, bid up to Day 11.
Moxifloxacin (MXF) Treatment Period (Treatment C)- participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon.
Participants received PSL, Placebo, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: ACB
Participants received PSL, MXF, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: BAC
Participants received Placebo, PSL, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: BCA
Participants received Placebo, MXF, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: CAB
Participants received MXF, PSL, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: CBA
Participants received MXF, Placebo, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Related to COVID-19 pandemic
|
3
|
4
|
3
|
3
|
3
|
3
|
Baseline Characteristics
A Study to Test the Cardiac Effects of Padsevonil in Healthy Study Participants
Baseline characteristics by cohort
| Measure |
Treatment Sequence: ABC
n=9 Participants
Padsevonil (PSL) Treatment Period (Treatment A) participants received PSL 100 milligrams (mg) to 400 mg, orally twice daily (bid) during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon.
Placebo Treatment Period (Treatment B) participants received Placebo matched to PSL Treatment Period doses, bid up to Day 11.
Moxifloxacin (MXF) Treatment Period (Treatment C) participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon.
Participants received PSL, Placebo, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: ACB
n=9 Participants
Participants received PSL, MXF, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: BAC
n=9 Participants
Participants received Placebo, PSL, and MXF treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: BCA
n=9 Participants
Participants received Placebo, MXF, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: CAB
n=9 Participants
Participants received MXF, PSL, and Placebo treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Treatment Sequence: CBA
n=9 Participants
Participants received MXF, Placebo, and PSL treatments at the first, the second and the third treatment periods respectively, with a minimum 7-day washout period between each treatment periods.
|
Total Title
n=54 Participants
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
35.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
30.2 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
36.8 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
32.4 years
STANDARD_DEVIATION 5.6 • n=10 Participants
|
35.1 years
STANDARD_DEVIATION 8.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
51 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other/mixed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment.
Placebo-corrected change from Baseline in corrected QT interval (QTc), based on Fridericia's correction (QTcF) method (ΔΔQTcF) evaluated during the Target Dose Day of the padsevonil and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=46 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
0.75 hour Predose
|
-1.2 milliseconds (ms)
Interval -4.0 to 1.6
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
0.5 hour Predose
|
-1.8 milliseconds (ms)
Interval -4.7 to 1.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
0.25 hour Predose
|
-0.7 milliseconds (ms)
Interval -3.5 to 2.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
0.25 hour Postdose
|
-0.5 milliseconds (ms)
Interval -3.6 to 2.6
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
0.5 hour Postdose
|
-0.9 milliseconds (ms)
Interval -3.8 to 1.9
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
1 hour Postdose
|
-1.8 milliseconds (ms)
Interval -4.6 to 1.0
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
1.5 hours Postdose
|
-1.3 milliseconds (ms)
Interval -4.2 to 1.5
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
2 hours Postdose
|
-1.8 milliseconds (ms)
Interval -4.7 to 1.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
3 hours Postdose
|
-2.5 milliseconds (ms)
Interval -6.0 to 1.0
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
4 hours Postdose
|
-1.5 milliseconds (ms)
Interval -4.6 to 1.6
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
6 hours Postdose
|
-0.6 milliseconds (ms)
Interval -3.8 to 2.5
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
8 hours Postdose
|
-2.0 milliseconds (ms)
Interval -5.3 to 1.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
12 hours Postdose
|
-2.9 milliseconds (ms)
Interval -7.1 to 1.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
18 hours Postdose
|
-4.9 milliseconds (ms)
Interval -8.1 to -1.7
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF on Day 8 for Padsevonil
24 hours Postdose
|
-1.5 milliseconds (ms)
Interval -4.8 to 1.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment.
Placebo-corrected change from Baseline in corrected QT interval (QTc), based on Fridericia's correction (QTcF) method (ΔΔQTcF) evaluated during the Target Dose Day of the moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=47 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
0.75 hour Predose
|
0.9 milliseconds
Interval -1.2 to 3.0
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
0.5 hour Predose
|
1.9 milliseconds
Interval -0.2 to 4.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
0.25 hour Predose
|
2.4 milliseconds
Interval 0.5 to 4.4
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
0.25 hour Postdose
|
1.8 milliseconds
Interval -0.5 to 4.0
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
0.5 hour Postdose
|
3.6 milliseconds
Interval 1.4 to 5.8
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
1 hour Postdose
|
8.6 milliseconds
Interval 6.2 to 10.9
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
1.5 hours Postdose
|
9.8 milliseconds
Interval 7.3 to 12.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
2 hours Postdose
|
10.6 milliseconds
Interval 8.0 to 13.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
3 hours Postdose
|
9.0 milliseconds
Interval 5.8 to 12.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
4 hours Postdose
|
9.0 milliseconds
Interval 6.4 to 11.7
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
6 hours Postdose
|
8.7 milliseconds
Interval 6.3 to 11.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
8 hours Postdose
|
8.6 milliseconds
Interval 6.2 to 11.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
12 hours Postdose
|
5.5 milliseconds
Interval 2.3 to 8.7
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
18 hours Postdose
|
7.9 milliseconds
Interval 5.3 to 10.5
|
—
|
—
|
|
Placebo-corrected Change From Baseline in QTcF After a Single Dose of Moxifloxacin on Day 8
24 hours Postdose
|
6.3 milliseconds
Interval 3.8 to 8.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment. The Target Dose for moxifloxacin was at Day 8. Therefore, the data was analyzed at Day 8 only.
Placebo-corrected change from Baseline in HR, (ΔΔHR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=50 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 0.25 hour Postdose
|
0.2 beats per minute (bpm)
Interval -0.8 to 1.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 0.5 hour Postdose
|
2.0 beats per minute (bpm)
Interval 0.6 to 3.4
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 1 hour Postdose
|
1.4 beats per minute (bpm)
Interval 0.0 to 2.8
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 1.5 hours Postdose
|
-0.1 beats per minute (bpm)
Interval -1.7 to 1.5
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 2 hours Postdose
|
0.1 beats per minute (bpm)
Interval -1.6 to 1.9
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 3 hours Postdose
|
-2.3 beats per minute (bpm)
Interval -4.2 to -0.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 4 hours Postdose
|
-2.0 beats per minute (bpm)
Interval -3.9 to -0.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 6 hours Postdose
|
0.8 beats per minute (bpm)
Interval -0.9 to 2.5
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 8 hours Postdose
|
-2.0 beats per minute (bpm)
Interval -3.7 to -0.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 12 hours Postdose
|
0.1 beats per minute (bpm)
Interval -1.6 to 1.8
|
—
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 1
Day 1: 24 hours Postdose
|
-0.8 beats per minute (bpm)
Interval -2.2 to 0.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment.
Placebo-corrected change from Baseline in HR, (ΔΔHR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=46 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=47 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 6 hours Postdose
|
-1.0 beats per minute (bpm)
Interval -3.2 to 1.2
|
0.2 beats per minute (bpm)
Interval -1.5 to 2.0
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 8 hours Postdose
|
-3.3 beats per minute (bpm)
Interval -5.1 to -1.5
|
0.2 beats per minute (bpm)
Interval -1.4 to 1.9
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 12 hours Postdose
|
-0.6 beats per minute (bpm)
Interval -2.4 to 1.3
|
0.3 beats per minute (bpm)
Interval -1.3 to 1.8
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 18 hours Postdose
|
1.1 beats per minute (bpm)
Interval -0.8 to 2.9
|
1.3 beats per minute (bpm)
Interval -0.6 to 3.2
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 0.75 hour Predose
|
-2.0 beats per minute (bpm)
Interval -3.7 to -0.2
|
-0.4 beats per minute (bpm)
Interval -1.9 to 1.2
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 0.5 hour Predose
|
-2.0 beats per minute (bpm)
Interval -3.6 to -0.4
|
0.4 beats per minute (bpm)
Interval -1.4 to 2.2
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 0.25 hour Predose
|
-1.1 beats per minute (bpm)
Interval -2.9 to 0.6
|
0.5 beats per minute (bpm)
Interval -1.3 to 2.3
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 0.25 hour Postdose
|
-1.1 beats per minute (bpm)
Interval -2.8 to 0.6
|
-0.4 beats per minute (bpm)
Interval -1.6 to 0.8
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 1.5 hours Postdose
|
-1.1 beats per minute (bpm)
Interval -2.7 to 0.5
|
1.3 beats per minute (bpm)
Interval -0.1 to 2.7
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 2 hours Postdose
|
-3.0 beats per minute (bpm)
Interval -4.6 to -1.4
|
1.0 beats per minute (bpm)
Interval -0.3 to 2.3
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 24 hours Postdose
|
-1.0 beats per minute (bpm)
Interval -3.2 to 1.2
|
0.4 beats per minute (bpm)
Interval -1.3 to 2.1
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 0.5 hour Postdose
|
-2.0 beats per minute (bpm)
Interval -3.7 to 0.4
|
0.1 beats per minute (bpm)
Interval -1.5 to 1.6
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 1 hour Postdose
|
-1.9 beats per minute (bpm)
Interval -3.5 to -0.3
|
1.9 beats per minute (bpm)
Interval 0.5 to 3.3
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 3 hours Postdose
|
-2.2 beats per minute (bpm)
Interval -4.4 to 0.0
|
-1.8 beats per minute (bpm)
Interval -3.5 to -0.1
|
—
|
|
Placebo-corrected Change From Baseline in Heart Rate (HR) Interval on Day 8
Day 8: 4 hours Postdose
|
-1.2 beats per minute (bpm)
Interval -3.3 to 0.8
|
-0.4 beats per minute (bpm)
Interval -2.0 to 1.3
|
—
|
SECONDARY outcome
Timeframe: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment. The Target Dose for moxifloxacin was at Day 8. Therefore, the data was analyzed at Day 8 only.
Placebo-corrected change from Baseline in PR, (ΔΔPR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=50 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 0.25 hour Postdose
|
-0.4 milliseconds
Interval -2.0 to 1.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 0.5 hour Postdose
|
0.5 milliseconds
Interval -1.2 to 2.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 1 hour Postdose
|
2.2 milliseconds
Interval 0.2 to 4.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 1.5 hours Postdose
|
1.9 milliseconds
Interval -0.2 to 3.9
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 2 hours Postdose
|
1.9 milliseconds
Interval -0.4 to 4.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 3 hours Postdose
|
2.2 milliseconds
Interval -0.3 to 4.7
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 4 hours Postdose
|
2.6 milliseconds
Interval -0.2 to 5.4
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 6 hours Postdose
|
2.3 milliseconds
Interval -0.7 to 5.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 8 hours Postdose
|
3.5 milliseconds
Interval 0.9 to 6.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 12 hours Postdose
|
1.3 milliseconds
Interval -1.8 to 4.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 1
Day 1: 24 hours Postdose
|
1.3 milliseconds
Interval -0.8 to 3.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment.
Placebo-corrected change from Baseline in PR, (ΔΔPR) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=46 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=47 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 0.75 hour Predose
|
2.4 milliseconds
Interval -0.4 to 5.2
|
-0.6 milliseconds
Interval -3.5 to 2.3
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 0.25 hour Predose
|
1.2 milliseconds
Interval -1.5 to 4.0
|
-1.2 milliseconds
Interval -4.1 to 1.7
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 0.25 hour Postdose
|
2.4 milliseconds
Interval -0.4 to 5.2
|
-0.4 milliseconds
Interval -3.1 to 2.4
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 0.5 hour Postdose
|
3.1 milliseconds
Interval 0.2 to 6.0
|
-1.6 milliseconds
Interval -4.3 to 1.1
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 1 hour Postdose
|
3.8 milliseconds
Interval 1.1 to 6.6
|
-0.8 milliseconds
Interval -3.3 to 1.7
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 1.5 hours Postdose
|
4.2 milliseconds
Interval 1.4 to 7.0
|
-0.8 milliseconds
Interval -3.3 to 1.7
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 2 hours Postdose
|
3.6 milliseconds
Interval 1.0 to 6.3
|
-1.3 milliseconds
Interval -3.7 to 1.2
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 3 hours Postdose
|
3.6 milliseconds
Interval 0.6 to 6.6
|
-3.1 milliseconds
Interval -6.1 to 0.0
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 4 hours Postdose
|
4.1 milliseconds
Interval 1.1 to 7.2
|
-3.3 milliseconds
Interval -6.2 to -0.3
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 24 hours Postdose
|
-0.6 milliseconds
Interval -2.1 to 3.3
|
-1.9 milliseconds
Interval -4.8 to 0.9
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 0.5 hour Predose
|
1.8 milliseconds
Interval -0.7 to 4.3
|
-1.0 milliseconds
Interval -3.7 to 1.7
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 6 hours Postdose
|
3.3 milliseconds
Interval 0.5 to 6.2
|
-2.3 milliseconds
Interval -4.9 to 0.4
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 8 hours Postdose
|
2.6 milliseconds
Interval -0.5 to 5.7
|
-2.3 milliseconds
Interval -4.8 to 0.2
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 12 hours Postdose
|
1.6 milliseconds
Interval -2.0 to 5.3
|
-2.9 milliseconds
Interval -6.0 to 0.1
|
—
|
|
Placebo-corrected Change From Baseline for PR Interval on Day 8
Day 8: 18 hours Postdose
|
-0.2 milliseconds
Interval -3.7 to 3.2
|
-2.1 milliseconds
Interval -5.3 to 1.1
|
—
|
SECONDARY outcome
Timeframe: Day 1 : 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment. The Target Dose for moxifloxacin was at Day 8. Therefore, the data was analyzed at Day 8 only.
Placebo-corrected change from Baseline for QRS interval, (ΔΔQRS) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=50 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day 1: 0.25 hour Postdose
|
-0.2 milliseconds
Interval -0.4 to 0.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day 1: 0.5 hour Postdose
|
-0.1 milliseconds
Interval -0.4 to 0.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day 1: 1 hour Postdose
|
0.0 milliseconds
Interval -0.2 to 0.3
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day 1: 2 hours Postdose
|
-0.3 milliseconds
Interval -0.6 to 0.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day1: 3 hours Postdose
|
-0.3 milliseconds
Interval -0.7 to 0.0
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day 1: 4 hours Postdose
|
-0.2 milliseconds
Interval -0.7 to 0.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day1: 6 hours Postdose
|
-0.1 milliseconds
Interval -0.6 to 0.4
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day1: 8 hours Postdose
|
-0.3 milliseconds
Interval -0.7 to 0.2
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day1: 12 hours Postdose
|
0.1 milliseconds
Interval -0.6 to 0.7
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day1: 24 hours Postdose
|
-0.3 milliseconds
Interval -0.6 to 0.1
|
—
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 1
Day 1: 1.5 hours Postdose
|
-0.2 milliseconds
Interval -0.5 to 0.1
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment.
Placebo-corrected change from Baseline for QRS interval, (ΔΔQRS) evaluated during the Target Dose Day of the padsevonil/moxifloxacin and placebo Treatment Periods, using linear mixed-effects model analysis.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=46 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=47 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 0.5 hour Predose
|
-0.1 milliseconds
Interval -0.9 to 0.6
|
0.0 milliseconds
Interval -0.7 to 0.7
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 0.25 hour Predose
|
-0.1 milliseconds
Interval -0.8 to 0.6
|
0.2 milliseconds
Interval -0.5 to 0.9
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 0.25 hour Postdose
|
-0.2 milliseconds
Interval -1.0 to 0.5
|
-0.1 milliseconds
Interval -0.8 to 0.7
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 0.5 hour Postdose
|
-0.2 milliseconds
Interval -1.0 to 0.5
|
-0.1 milliseconds
Interval -0.9 to 0.6
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 1 hour Postdose
|
-0.5 milliseconds
Interval -1.2 to 0.3
|
0.0 milliseconds
Interval -0.8 to 0.8
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 1.5 hours Postdose
|
-0.6 milliseconds
Interval -1.3 to 0.2
|
-0.1 milliseconds
Interval -0.8 to 0.7
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 2 hours Postdose
|
-0.2 milliseconds
Interval -1.0 to 0.6
|
0.1 milliseconds
Interval -0.7 to 0.8
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 3 hours Postdose
|
-0.2 milliseconds
Interval -0.9 to 0.6
|
0.1 milliseconds
Interval -0.5 to 0.8
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 4 hours Postdose
|
-0.3 milliseconds
Interval -1.1 to 0.4
|
0.0 milliseconds
Interval -0.7 to 0.7
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 6 hours Postdose
|
-0.4 milliseconds
Interval -1.2 to 0.4
|
-0.1 milliseconds
Interval -0.8 to 0.7
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 8 hours Postdose
|
0.0 milliseconds
Interval -0.8 to 0.8
|
0.0 milliseconds
Interval -0.7 to 0.6
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 12 hours Postdose
|
-0.2 milliseconds
Interval -1.0 to 0.6
|
0.5 milliseconds
Interval -0.4 to 1.3
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 18 hours Postdose
|
-1.1 milliseconds
Interval -2.0 to -0.2
|
-0.1 milliseconds
Interval -1.0 to 0.8
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 24 hours Postdose
|
-0.1 milliseconds
Interval -0.7 to 0.6
|
0.8 milliseconds
Interval 0.1 to 1.5
|
—
|
|
Placebo-corrected Change From Baseline for QRS Interval on Day 8
Day 8: 0.75 hour Predose
|
-0.2 milliseconds
Interval -0.9 to 0.6
|
0.0 milliseconds
Interval -0.7 to 0.8
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value. Here, number of participants were included who were evaluable for the assessment.
Number of Participants with treatment-emergent changes of electrocardiogram waveforms as T-waves and U-waves. If a given morphology occurs multiple times at a given time point, that occurrence was only counted 1 time for that time point. If more than 1 morphology type was observed at a given time point, both morphology types were counted. A subject can appear in more than 1 category.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=47 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
n=50 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Flat
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Notched (+)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Biphasic
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Normal (-)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
Notched (-)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Changes for T-wave Morphology and U-wave Presence
U-Wave Presence
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value.
Change from Baseline in QTcF (ΔQTcF) evaluated at drug-specific tmax (Δtmax) for padsevonil, using an analysis of variance (ANOVA) mixed-effect model.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Change From Baseline in QTcF Evaluated at Drug-specific Tmax for Padsevonil
|
-1.0 milliseconds
Interval -3.7 to 1.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value.
Change from Baseline in QTcF (ΔQTcF) evaluated at drug-specific tmax (Δtmax) for metabolite 1, using an analysis of variance (ANOVA) mixed-effect model.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Change From Baseline in QTcF Evaluated at Drug-specific Tmax for Metabolite 1
|
0.1 milliseconds
Interval -2.3 to 2.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 : 0.75, 0.5, 0.25 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdosePopulation: The QT/QTc Set included all study participants in the SS with measurements at Baseline as well as on-treatment with at least 1 postdose time point with a valid change-from Baseline QTcF (ΔQTcF) value.
Change from Baseline in QTcF (ΔQTcF) evaluated at drug-specific tmax (Δtmax) for metabolite 2, using an analysis of variance (ANOVA) mixed-effect model.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Change From Baseline in QTcF Evaluated at Drug-Specific Tmax for Metabolite 2
|
-1.0 milliseconds
Interval -3.5 to 1.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdosePopulation: The PKS included all study participants who received at least 1 dose of study medication, had no important Protocol deviations affecting the PK, and for whom at least 1 measurable PK concentration was available. Here, number of participants were included who were evaluable for the assessment.
Cmax,ss: Maximum observed plasma concentration of padsevonil at steady state.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=47 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration at Steady State (Cmax, ss) for Padsevonil
|
2119 nanogram per milliliter (ng/ml)
Interval 1912.0 to 2348.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdosePopulation: The PKS included all study participants who received at least 1 dose of study medication, had no important Protocol deviations affecting the PK, and for whom at least 1 measurable PK concentration was available. Here, number of participants were included who were evaluable for the assessment.
tmax: Time of observed maximum plasma concentration at steady state.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=47 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Time of Observed Maximum Concentration (Tmax) at Steady State for Padsevonil
|
0.5100 hours (h)
Interval 0.25 to 4.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8: 0.5 hours predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18 hours postdosePopulation: The PKS included all study participants who received at least 1 dose of study medication, had no important Protocol deviations affecting the PK, and for whom at least 1 measurable PK concentration was available. Here, number of participants were included who were evaluable for the assessment.
AUCtau: Area under the plasma concentration time curve over a dosing interval at steady state.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=47 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve (AUCtau) at Steady State for Padsevonil
|
8586 hour*nanogram per milliliter (h*ng/mL)
Interval 7752.0 to 9510.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Safety Follow-up (up to Day 67)Population: Safety Set included all participants who received at least 1 dose of study medication.
An Adverse Event is any untoward medical occurrence in a subject or trial subject 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 |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=51 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
n=50 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events From Baseline to Safety Follow-up (up to Day 67)
|
88.2 percentage of participants
|
31.4 percentage of participants
|
20.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Safety Follow-up (up to Day 67)Population: Safety Set included all participants who received at least 1 dose of study medication.
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 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 |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=51 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
n=50 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events From Baseline to Safety Follow-up (up to Day 67)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Safety Follow-up (up to Day 67)Population: Safety Set included all participants who received at least 1 dose of study medication.
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. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=51 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
n=50 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Percentage of Participants With Treatment Related Adverse Events From Baseline to Safety Follow-up (up to Day 67)
|
86.3 percentage of participants
|
5.9 percentage of participants
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Safety Follow-up (up to Day 67)Population: Safety Set included all participants who received at least 1 dose of study medication.
An Adverse Event is any untoward medical occurrence in a subject or trial subject 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. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Outcome measures
| Measure |
Padsevonil (QT/QTc Set)
n=51 Participants
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed the QT/corrected QT interval (QTc) Set.
|
Moxifloxacin (QT/QTc Set)
n=51 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11.
On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the QT/QTc Set.
|
Placebo (QT/QTc Set)
n=50 Participants
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the QT/QTc Set.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events Leading to Discontinuation of the Study From Baseline to Safety Follow-up (up to Day 67)
|
2.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Padsevonil (SS)
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Moxifloxacin (SS)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo (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 |
Padsevonil (SS)
n=51 participants at risk
Participants received PSL 100 mg to 400 mg orally bid during the 11 Days PSL Treatment Period. On Day 8, the Target Dose Day, participants received PSL 400 mg in the morning only and placebo in the afternoon. Participants formed Safety Set (SS).
|
Moxifloxacin (SS)
n=51 participants at risk
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. On Day 8, the Target Dose Day, participants received MXF 400 mg in the morning and placebo in the afternoon. Participants formed the SS.
|
Placebo (SS)
n=50 participants at risk
Participants received placebo matched to PSL Treatment Period doses, bid up to Day 11. Participants formed the SS.
|
|---|---|---|---|
|
Eye disorders
Diplopia
|
5.9%
3/51 • Number of events 3 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
3/51 • Number of events 3 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
2.0%
1/51 • Number of events 1 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
2.0%
1/50 • Number of events 1 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
General disorders
Medical device site reaction
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.9%
3/51 • Number of events 3 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
2/51 • Number of events 2 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
5.9%
3/51 • Number of events 3 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
2.0%
1/50 • Number of events 1 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Dizziness
|
41.2%
21/51 • Number of events 22 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
3.9%
2/51 • Number of events 2 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Sedation
|
29.4%
15/51 • Number of events 15 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
2.0%
1/51 • Number of events 1 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Headache
|
17.6%
9/51 • Number of events 13 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
9.8%
5/51 • Number of events 6 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
10.0%
5/50 • Number of events 5 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Somnolence
|
15.7%
8/51 • Number of events 8 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Memory impairment
|
11.8%
6/51 • Number of events 6 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Nervous system disorders
Disturbance in attention
|
5.9%
3/51 • Number of events 4 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Psychiatric disorders
Insomnia
|
7.8%
4/51 • Number of events 4 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
2.0%
1/50 • Number of events 1 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Psychiatric disorders
Irritability
|
7.8%
4/51 • Number of events 4 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/51 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
0.00%
0/50 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
7.8%
4/51 • Number of events 4 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
3.9%
2/51 • Number of events 2 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.
|
4.0%
2/50 • Number of events 2 • From Baseline to Safety Follow Up (up to Day 67)
Any AE that starts on or after the date of the first dose of study drug and on or before the last date of the last treatment period or any unresolved event already present before administration of treatment that worsens 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