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

NCT05901714 | Completed Phase 1 FDA Drug

• 1 other identifier: IM026-026
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Participants

Keywords

BMS-986256; Afimetoran; Midazolam; CYP3A4; Phenytoin

Outcome Measures

Primary Outcomes (3)

• Maximum observed plasma concentration (Cmax)

  Parts 1 and 2

  Up to 53 days

• Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])

  Parts 1 and 2

  Up to 53 days

• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

  Parts 1 and 2

  Up to 53 days

Secondary Outcomes (8)

• Time to attain maximum observed plasma concentration (Tmax)

  Up to 53 days

• Terminal half-life (T-Half)

  Up to 53 days

• Apparent total body clearance of the drug from the plasma (CLT/F)

  Up to 53 days

• Number of participants with adverse events (AEs)

  Up to 124 days

• Number of participants with clinical laboratory abnormalities

  Up to 66 days

Study Arms (2)

Part 1: Afimetoran followed by phenytoin + afimetoran

EXPERIMENTAL

Drug: Afimetoran; Drug: Phenytoin

Part 2: Midazolam followed by afimetoran + midazolam

EXPERIMENTAL

Drug: Afimetoran; Drug: Midazolam

Interventions

Afimetoran DRUG

Specified dose on specified days

Also known as: BMS-986256

Part 1: Afimetoran followed by phenytoin + afimetoran; Part 2: Midazolam followed by afimetoran + midazolam

Phenytoin DRUG

Specified dose on specified days

Part 1: Afimetoran followed by phenytoin + afimetoran

Midazolam DRUG

Specified dose on specified days

Part 2: Midazolam followed by afimetoran + midazolam

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Miami, Florida, 33136, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Phenytoin; Midazolam

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: June 14, 2023
• Primary Completion: April 11, 2024
• Study Completion: April 11, 2024
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)