Trial Outcomes & Findings for A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women (NCT NCT07542847)
NCT ID: NCT07542847
Last Updated: 2026-06-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.
Results posted on
2026-06-05
Participant Flow
Participants took part in the study from 19 September 2022 to 11 December 2022.
A total of 24 participants were enrolled in the study and was conducted in 2 parts, i.e. Part 1 and Part 2. In both parts, 24 participants received the study treatment, and 18 completed the study.
Participant milestones
| Measure |
Part 1: OPC-167832 and Itraconazole
Participants received a single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, twice daily (BID), on Day 8, followed by itraconazole, once daily (QD) from Day 9 to Day 25 of Part 1.
|
Part 2: OPC-167832 and Carbamazepine
Participants received a single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Part 1: OPC-167832 and Itraconazole
Participants received a single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, twice daily (BID), on Day 8, followed by itraconazole, once daily (QD) from Day 9 to Day 25 of Part 1.
|
Part 2: OPC-167832 and Carbamazepine
Participants received a single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
Baseline Characteristics
A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
Baseline characteristics by cohort
| Measure |
Part 1: OPC-167832 and Itraconazole
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, BID on Day 8, followed by itraconazole, QD from Day 9 to Day 25 of Part 1.
|
Part 2: OPC-167832 and Carbamazepine
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.5 years
STANDARD_DEVIATION 11.1 • n=20 Participants
|
39.8 years
STANDARD_DEVIATION 9.3 • n=20 Participants
|
38.6 years
STANDARD_DEVIATION 10.1 • n=40 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.Population: The Pharmacokinetics (PK) analysis set included all participants who received at least one dose of investigational medical product (IMP) and had at least one postdose evaluable plasma concentration. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=11 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832
|
81.0 nanograms per milliliter (ng/mL)
Standard Deviation 29.3
|
144 nanograms per milliliter (ng/mL)
Standard Deviation 66.7
|
PRIMARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25.Population: The PK analysis set included all participants who received at least one dose of IMP and had at least one postdose evaluable plasma concentration. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Outcome measures
| Measure |
OPC-167832
n=11 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=10 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 2: Cmax of OPC-167832
|
95.1 ng/mL
Standard Deviation 36.6
|
95.8 ng/mL
Standard Deviation 32.9
|
PRIMARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.Population: The PK analysis set included all participants who received at least one dose of IMP and had at least one postdose evaluable plasma concentration. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=11 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of OPC-167832
|
2310 Nanograms*hours per milliliter (ng*h/mL)
Standard Deviation 898
|
4490 Nanograms*hours per milliliter (ng*h/mL)
Standard Deviation 2390
|
PRIMARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25.Population: The PK analysis set included all participants who received at least one dose of IMP and had at least one postdose evaluable plasma concentration. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Outcome measures
| Measure |
OPC-167832
n=11 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=10 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 2: AUCt of OPC-167832
|
2280 ng*h/mL
Standard Deviation 808
|
1310 ng*h/mL
Standard Deviation 345
|
PRIMARY outcome
Timeframe: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.Population: The PK analysis set included all participants who received at least one dose of IMP and had at least one postdose evaluable plasma concentration. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Outcome measures
| Measure |
OPC-167832
n=11 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=9 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832
|
2180 ng*h/mL
Standard Deviation 619
|
3660 ng*h/mL
Standard Deviation 1170
|
PRIMARY outcome
Timeframe: Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25.Population: The PK analysis set included all participants who received at least one dose of IMP and had at least one postdose evaluable plasma concentration. Overall number of participants analyzed indicates the number of participants with data available for analysis.
Outcome measures
| Measure |
OPC-167832
n=10 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=7 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 2: AUCinfinity of OPC-167832
|
2330 ng*h/mL
Standard Deviation 868
|
1350 ng*h/mL
Standard Deviation 234
|
SECONDARY outcome
Timeframe: Part 1: Up to 8 weeks; Part 2: Up to 9 weeksPopulation: The safety analysis set included all enrolled participants who received at least one dose of IMP.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant administered a trial intervention and which does not necessarily have a causal relationship with this intervention. TEAEs are defined as AEs with an onset date on or after the start of IMP treatment.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Part 1: Up to 8 weeks; Part 2: Up to 9 weeksPopulation: The safety analysis set included all enrolled participants who received at least one dose of IMP.
Clinical laboratory tests for serum chemistry, hematology, and urinalysis were measured. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part 1: Up to 8 weeks; Part 2: Up to 9 weeksPopulation: The safety analysis set included all enrolled participants who received at least one dose of IMP.
Vital signs criteria for clinically significant changes: systolic blood pressure (greater than \[\>\]160 millimeters of mercury \[mmHg\] to less than \[\<\]90 mmHg), diastolic blood pressure (\>105 mmHg to \<50 mmHg), heart rate (\>110 beats per minute \[bpm\] to \<50 bpm), respiratory rate (\<12 breaths/min or \> 20 breaths/min), and temperature (\<36 degree Celsius \[°C\] or \>38°C).
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part 1: Up to 8 weeks; Part 2: Up to 9 weeksPopulation: The safety analysis set included all enrolled participants who received at least one dose of IMP. The safety analysis was planned to be conducted on the safety analysis set for Part 1 and Part 2, separately.
The physical examination included height (screening only), weight, and calculation of body mass index (BMI), as well as assessment of the head, neck, eyes, ears, nose, and throat; thorax; abdomen; skin and mucosae; neurological; and extremities. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Part 1: Up to 8 weeks; Part 2: Up to 9 weeksPopulation: The safety analysis set included all enrolled participants who received at least one dose of IMP. The safety analysis was planned to be conducted on the safety analysis set for Part 1 and Part 2, separately.
Electrocardiogram measurements included heart rate (HR), PR, QRS, RR, QT, QTcF, QTcB). The participants were assessed based on the clinically relevant changes in ECG values as per criteria defined in SAP.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Parts 1 and 2: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 9 weeksPopulation: The safety analysis set dataset included all enrolled participants who received at least one dose of IMP.
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation, suicidal behavior and non-suicidal self-injurious behavior. The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, suicidal behavior, completed suicide), suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan and intent) and non-suicidal self-injurious behavior.
Outcome measures
| Measure |
OPC-167832
n=12 Participants
Participants received a single OPC-167832 dose, orally on Days 1 and 15.
|
OPC-167832 and Itraconazole
Participants received a single OPC-167832 dose, orally on Days 1 and 15 and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25.
|
|---|---|---|
|
Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Behavior
|
0 Participants
|
—
|
|
Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
0 Participants
|
—
|
Adverse Events
Part 1: OPC-167832 and Itraconazole
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2: OPC-167832 and Carbamazepine
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: OPC-167832 and Itraconazole
n=12 participants at risk
Participants received a single OPC-167832 dose, orally on Days 1 and 15, and itraconazole, orally, BID on Day 8 followed by itraconazole, QD from Day 9 to Day 25 of Part 1.
|
Part 2: OPC-167832 and Carbamazepine
n=12 participants at risk
Participants received a single OPC-167832 dose, orally on Days 1 and 25, and carbamazepine Dose 1, orally, BID from Day 8 to Day 10, followed by Dose 2, BID from Day 11 to Day 13, and Dose 3, BID from Day 14 to Day 31 of Part 2.
|
|---|---|---|
|
Ear and labyrinth disorders
Eustachian Tube Dysfunction
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Ear and labyrinth disorders
Tinnitus
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Eye disorders
Vision Blurred
|
33.3%
4/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.7%
5/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Hematochezia
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
41.7%
5/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Vomitting
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
General disorders
Feeling Hot
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Infections and infestations
Conjunctivitis
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Infections and infestations
Otitis Externa
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Dizziness
|
25.0%
3/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
25.0%
3/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
41.7%
5/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
General disorders
Non-cardiac Chest Pain
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Aura
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Intention Tremor
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
16.7%
2/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Nervous system disorders
Speech Disorder
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Psychiatric disorders
Sleep Terror
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
|
Skin and subcutaneous tissue disorders
Dyshidrotic Eczema
|
0.00%
0/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
8.3%
1/12 • Part 1: Up to 8 weeks; Part 2: Up to 9 weeks
The safety analysis set included all enrolled participants who received at least one dose of IMP. As per the planned analysis, adverse events data were collected and summarized by study part. In Part 1, adverse events were summarized for participants receiving OPC-167832 with itraconazole, and in Part 2, for participants receiving OPC-167832 with carbamazepine, as all participants within each study part underwent the same treatment regimen.
|
Additional Information
Clinical Transparency
Otsuka Pharmaceutical Development & Commercialization, Inc.
Phone: 08446878522
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER