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

NCT07542847 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-05

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

OPC-167832

Oral tablets.

DRUG

Itraconazole

Oral solution.

DRUG

Carbamazepine

Oral tablets.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2022-11-18
Completion
2022-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542847 on ClinicalTrials.gov