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A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05866627
Collaborator
(none)
76
Enrollment
4
Arms
10.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Apr 7, 2024
Anticipated Study Completion Date :
Apr 7, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Afimetoran, followed by famotidine + afimetoran

Drug: Famotidine
Specified dose on specified days
Other Names:
  • Pepcid

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

    		•
    Experimental: Famotidine + afimetoran, followed by afimetoran

    Drug: Famotidine
    Specified dose on specified days
    Other Names:
  • Pepcid

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

    		•
    Experimental: Afimetoran

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

    		•
    Experimental: Famotidine, followed by afimetoran

    Drug: Famotidine
    Specified dose on specified days
    Other Names:
  • Pepcid

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to 20 Days]

    2. Time to attain maximum observed plasma concentration (Tmax) [Up to 20 Days]

    3. Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) [Up to 20 Days]

    Secondary Outcome Measures

    1. Number of participants with adverse events (AEs) [Up to 52 Days]

    2. Number of participants with clinical laboratory abnormalities [Up to 52 Days]

    3. Number of participants with vital sign abnormalities [Up to 52 Days]

    4. Number of participants with electrocardiogram (ECG) abnormalities [Up to 52 Days]

    Eligibility Criteria

    Criteria

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

    • Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m2) and 32.0 kg/m2, inclusive, at screening.

    • A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.

    • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

    Exclusion Criteria:

    • Any significant acute or chronic medical illness.

    • Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.

    • GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.

    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:
    NCT05866627
    Other Study ID Numbers:
    • IM026-1023
    • 1007296
    First Posted:
    May 19, 2023
    Last Update Posted:
    May 19, 2023
    Last Verified:
    May 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
    Famotidine
    Gastric pH
    Additional relevant MeSH terms:
    Famotidine

    Study Results

    No Results Posted as of May 19, 2023