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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

NCT ID: NCT05901714

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-14

Study Completion Date

2024-04-11

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Afimetoran followed by phenytoin + afimetoran

Group Type EXPERIMENTAL

Afimetoran

Intervention Type DRUG

Specified dose on specified days

Phenytoin

Intervention Type DRUG

Specified dose on specified days

Part 2: Midazolam followed by afimetoran + midazolam

Group Type EXPERIMENTAL

Afimetoran

Intervention Type DRUG

Specified dose on specified days

Midazolam

Intervention Type DRUG

Specified dose on specified days

Interventions

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Afimetoran

Specified dose on specified days

Intervention Type DRUG

Phenytoin

Specified dose on specified days

Intervention Type DRUG

Midazolam

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986256

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0001

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/content/studyconnect/us/en/clinical-trials/NCT05901714.html

BMS Clinical Trial Patient Recruiting

Other Identifiers

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IM026-026

Identifier Type: -

Identifier Source: org_study_id

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