A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
- Registration Number
- NCT05866627
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Afimetoran, followed by famotidine + afimetoran Afimetoran - Famotidine + afimetoran, followed by afimetoran Famotidine - Famotidine + afimetoran, followed by afimetoran Afimetoran - Afimetoran Afimetoran - Afimetoran, followed by famotidine + afimetoran Famotidine - Famotidine, followed by afimetoran Famotidine - Famotidine, followed by afimetoran Afimetoran -
- Primary Outcome Measures
Name Time Method Time to attain maximum observed plasma concentration (Tmax) Up to 20 Days Maximum observed plasma concentration (Cmax) Up to 20 Days 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
Name Time Method Number of participants with clinical laboratory abnormalities Up to 52 Days Number of participants with vital sign abnormalities Up to 52 Days Number of participants with electrocardiogram (ECG) abnormalities Up to 52 Days Number of participants with adverse events (AEs) Up to 52 Days
Trial Locations
- Locations (1)
Quotient Sciences
🇬🇧Nottingham, Nottinghamshire, United Kingdom