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BMS Recruiting Study icon

Recruiting

Trial ID IM026-026  |   NCT05901714

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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-55
    Age Range
  • 1
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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).

Nearest Recruiting Site

Key Eligibility Criteria

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.

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1: Afimetoran followed by phenytoin + afimetoran

ASSIGNED INTERVENTION
  • Drug: Afimetoran, Phenytoin

Study Arms

Experimental: Part 2: Midazolam followed by afimetoran + midazolam

ASSIGNED INTERVENTION
  • Drug: Afimetoran, Midazolam
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