Assessing how famotidine affects afimetoran levels in healthy volunteers
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
This study tests how the heartburn medicine famotidine affects the levels of afimetoran in healthy people.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 1 site (Nottingham, Nottinghamshire) |
| Trial ID | NCT05866627 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of famotidine on the drug levels of afimetoran in healthy participants. It aims to confirm that changes in gastric pH caused by famotidine do not significantly affect the pharmacokinetics of afimetoran. The study involves administering both medications to participants and monitoring their drug levels. The focus is on understanding the interaction between these two drugs in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates are healthy adults weighing at least 50 kg with a BMI between 18.0 and 32.0.
Not a fit: Patients with significant acute or chronic medical illnesses or recent gastrointestinal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into drug interactions that may improve medication safety and efficacy for patients requiring afimetoran.
How similar studies have performed: While this study focuses on a specific interaction, similar studies assessing drug interactions have shown varying degrees of success, indicating the potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nottingham, Nottinghamshire
- Quotient Sciences — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.