ICON plc
Lenexa, Kansas, 66219, United States
NCT Number: NCT07542847
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Oral tablets.
Oral solution.
Oral tablets.
Time frame: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.
Time frame: Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25.
Time frame: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.
Time frame: Predose and up to 168 hours postdose on Day 1; and Predose and up to 168 hours postdose on Day 25.
Time frame: Predose and up to 168 hours postdose on Day 1; and Predose and up to 264 hours postdose on Day 15.
Time frame: Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Otsuka Pharmaceutical Development & Commercialization, Inc.
Industry
A Phase 1, Single-center, Two-part, Open-label, Pharmacokinetic Trial to Assess the Potential for Cytochrome P450 3A Mediated Drug-drug Interactions With Orally Administered OPC-167832 Tablets in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial DetailsNCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial DetailsNCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial DetailsNCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details