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COMPLETED
NCT07542847
PHASE1

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

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2022-09-19

Completion Date

2022-12-11

Last Updated

2026-06-05

Healthy Volunteers

Yes

Interventions

DRUG

OPC-167832

Oral tablets.

DRUG

Itraconazole

Oral solution.

DRUG

Carbamazepine

Oral tablets.

Locations (1)

ICON plc

Lenexa, Kansas, United States