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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
ICON plc
Lenexa, Kansas, United States
Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25.
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.
Time frame: 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 Clinical Laboratory Test Parameters
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Clinical laboratory tests for serum chemistry, hematology, and urinalysis were measured. Clinical significance was determined by the investigator.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 9 weeks