Healthy Volunteers
Conditions
Keywords
BMS-986256, Famotidine, Gastric pH
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.
Interventions
DRUGFamotidine
Specified dose on specified days
DRUGAfimetoran
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 20 Days |
| Time to attain maximum observed plasma concentration (Tmax) | 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
| Measure | Time frame |
|---|---|
| Number of participants with adverse events (AEs) | Up to 52 Days |
| 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 |
Countries
United Kingdom
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed