Healthy Volunteers Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 76 |
| Est. completion date | April 7, 2024 |
| Est. primary completion date | March 24, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Quotient Sciences | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 20 Days | ||
| Primary | Time to attain maximum observed plasma concentration (Tmax) | Up to 20 Days | ||
| Primary | 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 | Number of participants with adverse events (AEs) | Up to 52 Days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 52 Days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 52 Days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 52 Days |
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