RecruitingPhase 1NCT05866627
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
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
Sponsor
Bristol-Myers Squibb
Enrollment
76 participants
Start Date
Jul 4, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
DRUGFamotidine
Specified dose on specified days
DRUGAfimetoran
Specified dose on specified days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05866627
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