CompletedPhase 1

A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women

United States24 participantsStarted 2022-09-19

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
. Medical history
. Physical examination
. ECG
. Serum/urine chemistry, hematology, and serology tests
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25.

Trial details

NCT IDNCT07542847

SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-18

Results submitted2026-04-22

View on ClinicalTrials.gov More Healthy Volunteers trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
. Medical history
. Physical examination
. ECG
. Serum/urine chemistry, hematology, and serology tests
. 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

What they're measuring

Part 1: Maximum Plasma Concentration (Cmax) of OPC-167832

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Predose and upto 168 hours postdose on Day 1; and Predose and upto 168 hours postdose on Day 25.