A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Afimetoran; Drug: Midazolam; Drug: Phenytoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05901714

IM026-026

Details and patient eligibility

About

This study will consist of 2 parts. The study will evaluate whether administration of phenytoin impacts the single-dose drug levels of afimetoran and BMT-271199 (Part 1) and will evaluate whether multiple administrations of afimetoran impact the drug levels of midazolam and 1-hydroxymidazolam (Part 2).

Enrollment: 65 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) of 19.0 kilograms per meter squared (kg/m^2) to 32.0 kg/m2, inclusive, and body weight ≥ 55 kg, at screening.

Exclusion criteria

• Any significant acute or chronic medical illness or any other condition listed as a contraindication in the phenytoin (Part 1) or midazolam (Part 2) package inserts.
• History of seizure (including simple febrile seizure), epilepsy, severe head injury (including concussion), multiple sclerosis, or other known neurological condition which the investigator considers to be clinically significant.
• Current or recent (within 3 months of study intervention administration) GI disease that could impact upon the absorption of study intervention.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Part 1: Afimetoran followed by phenytoin + afimetoran

Experimental group

Treatment:

Drug: Phenytoin

Drug: Afimetoran

Part 2: Midazolam followed by afimetoran + midazolam

Experimental group

Treatment:

Drug: Midazolam

Drug: Afimetoran