Trial Outcomes & Findings for Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder (NCT NCT01423916)
NCT ID: NCT01423916
Last Updated: 2015-10-29
Results Overview
Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
218 participants
Primary outcome timeframe
Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)
Results posted on
2015-10-29
Participant Flow
A randomized, double-blind, placebo and positive-controlled, parallel-arm study to examine the effects of 2 dose levels of brexpiprazole on the QT/QTc (QT interval corrected for heart rate) interval. This study was run in 8 sites in the US.
Participants were screened from Days -28 to -6 and washed out from their current antipsychotic medication between Days -5 to -2 and resumed antipsychotic therapy by study physician on Day 13 or at early termination (ET). A safety Follow-up was done 30 (+2) days after last dose of study medication.
Participant milestones
| Measure |
Brexpiprazole 4mg
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 12mg
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Moxifloxacin/Placebo
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
|---|---|---|---|
|
Overall Study
STARTED
|
74
|
73
|
71
|
|
Overall Study
COMPLETED
|
63
|
53
|
64
|
|
Overall Study
NOT COMPLETED
|
11
|
20
|
7
|
Reasons for withdrawal
| Measure |
Brexpiprazole 4mg
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 12mg
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Moxifloxacin/Placebo
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
9
|
2
|
|
Overall Study
Met Withdrawal Criteria
|
1
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
3
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
Baseline Characteristics
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Baseline characteristics by cohort
| Measure |
Brexpiprazole 4mg
n=74 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprzole 12mg
n=73 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Moxifloxacin/Placebo
n=71 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.5 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
37.5 Years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
38.2 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
38.1 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 11 (Hours 1, 2, 3, 4, 5, 6, 8, 12, 16, 24)Population: The dataset quantitates effect of brexpiprazole on individual QTcI corrected for placebo of the completer population where participants received study medication from Day 1 to Day 11 (placebo at Day 1) had 1 Predose and Post-dose time-matched ECG assessments on Day 1 and Day 11. The first 5 time points for moxifloxacin arm only were 2-sided 98% CI.
Pharmacodynamics endpoint is the time-matched corrected QT interval (QTcI) change from baseline (Day -1) corrected for placebo on Day 11 following brexpiprazole treatment. The primary QT to QTc correction formula (QTcI) was determined for each participant using the participant's baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k was derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=64 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 1 (N=61, 53, 61)
|
9.2 msec
Interval 5.8 to 12.6
|
-0.2 msec
Interval -5.2 to 4.8
|
2.6 msec
Interval -2.2 to 7.4
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 2 (N= 62, 53, 62)
|
9.4 msec
Interval 6.0 to 12.8
|
-0.2 msec
Interval -5.0 to 4.5
|
1.2 msec
Interval -3.4 to 5.7
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 3 (N= 60, 51, 61)
|
8.5 msec
Interval 5.1 to 11.9
|
1.3 msec
Interval -3.4 to 6.0
|
1.1 msec
Interval -3.4 to 5.6
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 4 (N= 62, 53, 62)
|
10.5 msec
Interval 7.1 to 13.8
|
3.1 msec
Interval -1.7 to 8.0
|
3.6 msec
Interval -1.0 to 8.3
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 5 (N= 62, 52, 62)
|
6.2 msec
Interval 2.8 to 9.5
|
-0.2 msec
Interval -5.1 to 4.6
|
1.7 msec
Interval -2.9 to 6.3
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 6 (N= 61, 52, 62)
|
7.3 msec
Interval 3.8 to 10.7
|
1.3 msec
Interval -3.5 to 6.1
|
8.3 msec
Interval -3.7 to 12.9
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 8 (N= 59, 50, 59)
|
7.5 msec
Interval 4.1 to 10.9
|
2.5 msec
Interval -2.0 to 6.9
|
4.0 msec
Interval -0.2 to 8.3
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 10 (N= 59, 47, 56)
|
9.0 msec
Interval 5.5 to 12.4
|
2.2 msec
Interval -2.3 to 6.8
|
5.2 msec
Interval 0.8 to 9.5
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 12 (N= 58, 47, 58)
|
6.8 msec
Interval 3.3 to 10.3
|
2.6 msec
Interval -2.2 to 7.4
|
5.3 msec
Interval 0.7 to 9.9
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 16 (N= 59, 48, 53)
|
2.2 msec
Interval -1.3 to 5.7
|
0.8 msec
Interval -3.9 to 5.5
|
4.0 msec
Interval -0.6 to 8.5
|
—
|
|
Time-matched QTcI Change From Baseline (Day -1) Corrected for Placebo on Day 11 Following Brexpiprazole Treatment.
Hours 24 (N= 54, 45, 57)
|
2.1 msec
Interval -1.5 to 5.7
|
0.7 msec
Interval -4.2 to 5.7
|
0.1 msec
Interval -4.6 to 4.8
|
—
|
PRIMARY outcome
Timeframe: AEs were recorded from Screening (informed consent was signed) during the 12-day treatment period to follow-up 30 (+ 2) days post-last dose of study medicationPopulation: Safety dataset of randomized participants received 1 dose of study medication after Day 1.
Clinically important changes in vital signs, physical examinations, laboratory tests and ECGs were by and large reflected in AE/SAE (which are presented in safety section) of this report.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=70 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=67 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=65 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=68 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Hyperglycaemia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Postural orthostatic tachycardia syndrome
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Tachycardia
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Blood creatinine phosphokinase increased
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Blood pressure increased
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Blood prolactin increased
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Hepatic enzyme increased
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Liver function test abnormal
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AE) and Clinically Important Changes in Vital Signs, Physical Examinations, Laboratory Tests, and Standard ECGs (Electrocardiogram).
Weight increased
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 11Population: Pharmacokinetics (PK) analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.
Pharmacokinetics endpoint is the maximum (peak) plasma concentration (Cmax) of brexpiprazole and moxifloxacin. Values for Cmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=63 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=64 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Maximum Peak Plasma Concentration (Cmax) of Brexpiprazole and Moxifloxacin.
|
170 ng/mL
Standard Deviation 69.8
|
462 ng/mL
Standard Deviation 249
|
2760 ng/mL
Standard Deviation 659
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations.
Pharmacokinetics endpoint is the time to maximum (peak) plasma concentration (tmax) of brexpiprazole and moxifloxacin. Values for tmax were determined directly from the observed data. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=63 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=64 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Time to Maximum (Peak) Plasma Concentration (Tmax) of Brexpiprazole and Moxifloxacin.
|
3.54 Hours
Interval 1.0 to 8.0
|
3.00 Hours
Interval 0.0 to 8.0
|
1.25 Hours
Interval 0.0 to 5.0
|
—
|
PRIMARY outcome
Timeframe: Day 11Population: PK analysis dataset consisted of all evaluable PK parameters from randomized participants who had plasma concentrations. For Moxifloxacin group, area under the plasma concentration-time curve was calculated to the last observable concentration.
Pharmacokinetics endpoint is the area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of brexpiprazole and moxifloxacin. Area under the plasma concentration-time curve during the dosing interval at steady-state (AUCT) value was estimated using the linear trapezoidal rule; the value reported represent the area under the curves to the last time point during that day. Blood samples were collected on Days -1, 1, 11, and 12 at predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose or at ET.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=63 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=64 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Curve During Dosing (AUCT).
|
3100 ng*h/mL
Standard Deviation 1400
|
8880 ng*h/mL
Standard Deviation 5110
|
28400 ng*h/mL
Standard Deviation 6350
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 11Population: Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days -1 and 11.
New onset (\> 450, \> 480, or \> 500 msec) in QTc was defined as a participant who attained a QTc \> 450, \> 480, \> 500 msec during Day 11 but not on Day -1. The number of participants were noted with time-matched change in mean QTcI change from Baseline for assay sensitivity of moxifloxacin treatment corrected for placebo. The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k).
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.
QTcI (> 450 msec)
|
5 participants
|
4 participants
|
5 participants
|
0 participants
|
|
Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.
QTcI (> 480 msec)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants Noted With Time-matched Change in Mean QTcI Change From Baseline for Assay Sensitivity of Moxifloxacin Treatment Corrected for Placebo at Day 11.
QTcI (> 500 msec)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Day 11Population: Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change form Baseline in summary of maximun QTcI on Day 11 minus mean QTcI on Day -1 (Baseline) is presented here.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=62 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Mean QTcI on Day -1 (Baseline).
|
11.6 msec
Standard Deviation 7.4
|
12.4 msec
Standard Deviation 10.4
|
10.6 msec
Standard Deviation 7.7
|
-1.1 msec
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: Baseline, Day 11Population: Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days -1 and 11.
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). The change from Baseline in summary of maximum QTcI on Day 11 minus maximum QTcI on Day -1 (Baseline) is presented here.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=62 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Change From Baseline in Summary of Maximum QTcI on Day 11 Minus Maximum QTcI on Day -1 (Baseline).
|
0.4 msec
Standard Deviation 9.1
|
0.9 msec
Standard Deviation 10.9
|
0.0 msec
Standard Deviation 8.1
|
-1.2 msec
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Day 11Population: Assay sensitivity dataset shows the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed were total number of participants with both Baseline and at least one observation of the given parameter.
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change between 30 to 60 msec were presented here.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number of Participants With QTcI Interval Between 30 and 60 Msec on Day 11.
|
4 participants
|
1 participants
|
11 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 11Population: Assay sensitivity dataset demonstrated the effect of moxifloxacin on QTcI from randomized participants in moxifloxacin and placebo arms who had evaluable time-matched ECG assessments on Days -1, 1, 11, and 12. Number of participants analyzed included those who had observations in QTc at both Days -1 and 11.
The primary QT to QTc correction formula (QTcI) were determined for each participant using the participant's Baseline (Day -1 placebo) ECG data. The QT correction formula QT / (RR)k were derived using log-log-linear regression, where log (QT) = a + k × log (RR) + ε to estimate the exponent (k). Participants with QTcI interval change of \> 60 msec on Day 11 were presented here.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number of Participants With QTcI Interval > 60 Msec on Day 11.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 11Population: Assay sensitivity sample dataset demonstrated the ability of the trial that detected the effect of moxifloxacin on the QTcI that consisted from randomized participants in moxifloxacin and placebo arms, who had evaluable time-matched ECG assessments in both periods (Day -1/1 or Day 11/12) in placebo and moxifloxacin on Days -1, 1, 11, and 12.
The number of participants who were noted with new incidence of QT interval of \> 500 msec on Day 11 and a 12-lead ECG was used.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number Participants Noted With New Incidence of QT Interval of > 500 Msec on Day 11.
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 11Population: Number of participants who took at least one dose of study drug post Day -1, and had evaluations of the ECG parameters at Baseline and Post Baseline.
Participants with incidence of ECG morphology abnormalities on Day 11 (participants who had abnormalities during Day 11 but not at Day -1) were noted. Types of abnormalities included appearance of abnormal U waves, negative T waves, elevation of ST segment, depression of ST segment, second degree heart block, third degree heart block, right bundle branch block, and left bundle branch block. ECGs were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
U Wave abnormalities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Negative T Waves
|
4 participants
|
7 participants
|
8 participants
|
6 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Depression of ST segment
|
2 participants
|
2 participants
|
4 participants
|
1 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Elevation of ST segment
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Second degree heart block
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Third degree heart block
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Right bundle branch block
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With New Incidence of ECG Morphology Abnormalities on Day 11.
Left bundle branch block
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Day 11Population: Electrocardiograms were sampled at predose and approximately 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours postdose on Days -1, 1, 11, and 12.
Changes in HR with values 25% decrease from Day -1 and HR \< 50 bpm and 25% increase from Day -1 and HR \> 100 bpm; PR interval of greater than or equal to 25% change from Day -1 and PR \> 200 msec; QRS interval of Greater than or equal to 25% change from Day -1 and \> 100 msec were noted on Day 11. Maximum change from baseline to the on-treatment ECG values on Day 11 for heart rate.
Outcome measures
| Measure |
Moxifloxacin/Placebo
n=62 Participants
Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
|
Brexpiprazole 12mg
n=53 Participants
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 4mg
n=63 Participants
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Placebo
n=62 Participants
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
HR: < 50 bpm
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
HR: > 100 bpm
|
5 participants
|
7 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
PR > 200 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Maximum Change From Baseline to the On-treatment ECG Values on Day 11 for Heart Rate (HR), PR Interval, and QRS Interval.
QRS > 100 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Brexpiprazole 4mg
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Brexpiprazole 12mg
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Moxifloxacin
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brexpiprazole 4mg
n=70 participants at risk
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 12mg
n=67 participants at risk
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Moxifloxacin
n=65 participants at risk
Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
|
Placebo
n=68 participants at risk
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Psychiatric disorders
Schizoaffective disorder
|
1.4%
1/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
0.00%
0/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
0.00%
0/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
0.00%
0/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
Other adverse events
| Measure |
Brexpiprazole 4mg
n=70 participants at risk
Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Brexpiprazole 12mg
n=67 participants at risk
Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
|
Moxifloxacin
n=65 participants at risk
Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
|
Placebo
n=68 participants at risk
Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.3%
3/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
6.0%
4/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
7/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
7.5%
5/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
5.9%
4/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
General disorders
Application site dermatitis
|
8.6%
6/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
3.1%
2/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
5.9%
4/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Nervous system disorders
Akathisia
|
7.1%
5/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
7.5%
5/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Nervous system disorders
Dizziness
|
8.6%
6/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
11.9%
8/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
3.1%
2/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Nervous system disorders
Extrapyramidal disorder
|
5.7%
4/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
7.5%
5/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
0.00%
0/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Nervous system disorders
Somnolence
|
4.3%
3/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
6.0%
4/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
1.5%
1/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Psychiatric disorders
Insomnia
|
4.3%
3/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
6.0%
4/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
0.00%
0/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
4.4%
3/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Psychiatric disorders
Restlessness
|
2.9%
2/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
7.5%
5/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
0.00%
0/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
4.4%
3/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
7.5%
5/67 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
3.1%
2/65 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
5.9%
4/68 • AEs were recorded from Screening (informed consent was signed) throughout the 12-day treatment period until follow-up of up to 30 (+ 2) days post-last dose of study medication.
The safety dataset consisted of all randomized participants who had received at least 1 oral dose of study medication after Baseline (Day 1) to Day 12.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place