Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this trial is to assess the potential for cytochrome P450 (CYP)-mediated drug-drug interactions (DDIs) with OPC-167832. The study is conducted in 2 parts: Part 1 assesses the potential effect of the CYP3A inhibitor itraconazole on the metabolism of OPC-167832 and Part 2 assesses the potential effect of the CYP3A inducer carbamazepine on the metabolism of OPC-167832 in healthy adult participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: OPC-167832 and Itraconazole | Experimental | Participants receive 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 | Experimental | Participants receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-167832 | Drug | Oral tablets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832 | Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. | |
| Part 2: Cmax of OPC-167832 | Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25. | |
| Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of OPC-167832 | Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. | |
| Part 2: AUCt of OPC-167832 | Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25. | |
| Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832 | Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. | |
| Part 2: AUCinfinity of OPC-167832 | Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25. |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
Not provided
Inclusion Criteria
Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m^2), inclusive.
In good health at screening as determined by:
Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial
Exclusion Criteria
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc | Lenexa | Kansas | 66219 | United States |
Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Not provided
Not provided
Not provided
Not provided
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.
Participants took part in the study from 19 September 2022 to 11 December 2022.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The enrolled analysis dataset includes all participants that signed the informed consent form (ICF) and met all eligibility criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: 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 of Part 1. |
| BG001 | Part 2: OPC-167832 and Carbamazepine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832 | 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. | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: 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 of Part 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eustachian Tube Dysfunction | Ear and labyrinth disorders | MedDRA25.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Otsuka Pharmaceutical Development & Commercialization, Inc. | 08446878522 | clinicaltransparency@otsuka-us.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2022 | Apr 22, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 26, 2022 | Apr 22, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Itraconazole | Drug | Oral solution. |
|
| Carbamazepine | Drug | Oral tablets. |
|
| Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters | Clinical laboratory tests for serum chemistry, hematology, and urinalysis were measured. Clinical significance was determined by the investigator. | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
| Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities | 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). | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
| Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations | 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. | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
| Parts 1 and 2: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Parameters | 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. | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
| Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | Up to 9 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
| Primary | Part 2: Cmax of OPC-167832 | 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. | Posted | Mean | Standard Deviation | ng/mL | Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25. |
|
|
|
|
| Primary | Part 1: Area Under the Concentration-time Curve Calculated to the Last Observable Concentration at Time t (AUCt) of OPC-167832 | 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. | Posted | Mean | Standard Deviation | Nanograms*hours per milliliter (ng*h/mL) | Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. |
|
|
|
|
| Primary | Part 2: AUCt of OPC-167832 | 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. | Posted | Mean | Standard Deviation | ng*h/mL | Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25. |
|
|
|
|
| Primary | Part 1: Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinfinity) of OPC-167832 | 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. | Posted | Mean | Standard Deviation | ng*h/mL | Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15. |
|
|
|
|
| Primary | Part 2: AUCinfinity of OPC-167832 | 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. | Posted | Mean | Standard Deviation | ng*h/mL | Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25. |
|
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 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. | The safety analysis set included all enrolled participants who received at least one dose of IMP. | Posted | Count of Participants | Participants | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters | Clinical laboratory tests for serum chemistry, hematology, and urinalysis were measured. Clinical significance was determined by the investigator. | The safety analysis set included all enrolled participants who received at least one dose of IMP. | Posted | Count of Participants | Participants | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities | 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). | The safety analysis set included all enrolled participants who received at least one dose of IMP. | Posted | Count of Participants | Participants | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations | 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. | 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. | Posted | Count of Participants | Participants | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
|
|
|
| Secondary | Parts 1 and 2: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Parameters | 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. | 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. | Posted | Count of Participants | Participants | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks |
|
|
|
| Secondary | Part 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) | 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. | The safety analysis set dataset included all enrolled participants who received at least one dose of IMP. | Posted | Count of Participants | Participants | Up to 9 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 10 | 12 |
| Tinnitus | Ear and labyrinth disorders | MedDRA25.0 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA25.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Otitis Externa | Infections and infestations | MedDRA25.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA25.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Non-cardiac Chest Pain | General disorders | MedDRA25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Aura | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Disturbance in Attention | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Intention Tremor | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Speech Disorder | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
|
| Abnormal Dreams | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
|
| Sleep Terror | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA25.0 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
| Dyshidrotic Eczema | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
|
Not provided
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010879 |
| Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |