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A Study to Test the Effects of Itraconazole and Carbamazepine on OPC-167832 in Healthy Men and Women
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
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
Conditions
Interventions
OPC-167832
Oral tablets.
Itraconazole
Oral solution.
Carbamazepine
Oral tablets.
Locations (1)
ICON plc
Lenexa, Kansas, United States