Healthy Volunteers
Conditions
Keywords
Tuberculosis, TB
Brief summary
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.
Interventions
DRUGOPC-167832
Oral tablets.
DRUGItraconazole
Oral solution.
DRUGCarbamazepine
Oral tablets.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body mass index (BMI) between 19.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive. 2. In good health at screening as determined by: 1. Medical history 2. Physical examination 3. ECG 4. Serum/urine chemistry, hematology, and serology tests 3. 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
1. Clinically significant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participants at risk or interfere with outcome variables including absorption, distribution, metabolism, and excretion of drug. 2. History of drug and/or alcohol abuse (as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for moderate to severe alcohol/substance use disorder) within 2 years prior to the screening visit. 3. History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus antibodies. 4. History of any clinically significant drug allergy or known or suspected hypersensitivity, to any component of the IMP including structurally related drugs (eg, tricyclic antidepressants), hereditary fructose intolerance (Part 1 only), or any of the excipients. 5. A positive urine alcohol test and/or urine drug screen for substances of abuse at the screening visit or upon check-in to the trial site. 6. Participants having taken an investigational drug within 30 days prior to the screening visit. 7. Any history of clinically significant hemorrhagic tendencies. 8. Having received a vaccine within 14 days prior to dosing 9. Any participant who, in the opinion of the investigator, should not participate in the trial. 10. Female participants who are breast-feeding or who have a positive pregnancy test result prior to receiving IMP. 11. Participants without a permanent physical residence. 12. History of suicide ideation or severe depression that, in the opinion of the investigator, would exclude the participant from participating in this trial (applicable to Part 2 only). Note: Other protocol-specified inclusion/
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks | 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. |
| Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks | Clinical laboratory tests for serum chemistry, hematology, and urinalysis were measured. Clinical significance was determined by the investigator. |
| Parts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks | 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). |
| Parts 1 and 2: Number of Participants With Potentially Clinically Significant Changes in Physical Examinations | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks | 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. |
| Parts 1 and 2: Number of Participants With Potentially Clinically Relevant Changes in 12-lead Electrocardiogram (ECG) Parameters | Part 1: Up to 8 weeks; Part 2: Up to 9 weeks | 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 2: Number of Participants With Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 9 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study from 19 September 2022 to 11 December 2022.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 10.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 4 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 7 / 12 | 10 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
None listed