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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05901714
Collaborator
(none)
50
Enrollment
2
Arms
4.1
Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Single-sequence, Drug-drug Interaction Study in Healthy Participants to Assess the Effect of Phenytoin on the Pharmacokinetics of a Single Oral Dose of Afimetoran (BMS-986256) (Part 1) and the Effect of Steady-state Afimetoran on the Pharmacokinetics of Midazolam (Part 2)
Anticipated Study Start Date :
Jun 14, 2023
Anticipated Primary Completion Date :
Oct 17, 2023
Anticipated Study Completion Date :
Oct 17, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: Afimetoran followed by phenytoin + afimetoran

Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256

    • Drug: Phenytoin
    Specified dose on specified days
    Experimental: Part 2: Midazolam followed by afimetoran + midazolam

    Drug: Afimetoran
    Specified dose on specified days
    Other Names:
  • BMS-986256

    • Drug: Midazolam
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to 53 days]

      Parts 1 and 2

    2. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) [Up to 53 days]

      Parts 1 and 2

    3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 53 days]

      Parts 1 and 2

    Secondary Outcome Measures

    1. Time to attain maximum observed plasma concentration (Tmax) [Up to 53 days]

      Parts 1 and 2

    2. Terminal half-life (T-Half) [Up to 53 days]

      Parts 1 and 2

    3. Apparent total body clearance of the drug from the plasma (CLT/F) [Up to 53 days]

      Parts 1 and 2

    4. Number of participants with adverse events (AEs) [Up to 124 days]

      Parts 1 and 2

    5. Number of participants with clinical laboratory abnormalities [Up to 66 days]

      Parts 1 and 2

    6. Number of participants with physical examination abnormalities [Up to 66 days]

      Parts 1 and 2

    7. Number of participants with vital sign abnormalities [Up to 66 days]

      Parts 1 and 2

    8. Number of participants with electrocardiogram (ECG) abnormalities [Up to 66 days]

      Parts 1 and 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05901714
    Other Study ID Numbers:
    • IM026-026
    First Posted:
    Jun 13, 2023
    Last Update Posted:
    Jun 13, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    BMS-986256
    Afimetoran
    Midazolam
    CYP3A4
    Phenytoin
    Additional relevant MeSH terms:
    Phenytoin
    Midazolam

    Study Results

    No Results Posted as of Jun 13, 2023