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

• Status: Not yet recruiting
• Trial end date: 2024-04-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Famotidine

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.