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NCT05866627 | RECRUITING | Healthy Volunteers

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

Bristol-Myers Squibb

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

Healthy Volunteers

Intervention/treatment

Famotidine

Afimetoran

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 76 participants
Masking : NONE
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
Actual Study Start Date : 2023-07-04
Estimated Primary Completion Date : 2026-03-01
Estimated Study Completion Date : 2026-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m\^2) and 32.0 kg/m\^2, 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.
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants

Location Details

NCT05866627

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United Kingdom, Nottinghamshire

Quotient Sciences

Nottingham, Nottinghamshire, United Kingdom, Ng11 6Js