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

Last updated: January 20, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Famotidine

Afimetoran

Clinical Study ID

NCT05866627
IM026-1023
1007296
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass indexbetween 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, atscreening.

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

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

Exclusion

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 ofstudy treatment, at the investigator's discretion.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: Famotidine
Phase: 1
Study Start date:
July 04, 2023
Estimated Completion Date:
March 01, 2026

Connect with a study center

  • Quotient Sciences

    Nottingham, Nottinghamshire NG11 6JS
    United Kingdom

    Active - Recruiting

  • Local Institution - 0001

    Nottingham, NG11 6JS
    United Kingdom

    Active - Recruiting

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