Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
- Registration Number
- NCT04470778
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to investigate the effect of gastric pH changes due to famotidine administration on the drug levels of prototype BMS-986256 tablet formulation in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Healthy participants having no clinically significant deviations from normal in medical history, physical examination (PE) findings, electrocardiograms (ECGs), vital signs, and clinical laboratory results that would compromise the ability to participate, complete, and/or interpret the results of the study
- Weight ≥ 50 kg and body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2 inclusive at screening
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Any significant acute or chronic medical illness
- Any major surgery within 4 weeks of study treatment administration
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BMS-986256 BMS-986256 - BMS-986256 + Famotidine Famotidine - BMS-986256 + Famotidine BMS-986256 -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 39 days Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration AUC(0-T) Up to 39 days Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) Up to 39 days
- Secondary Outcome Measures
Name Time Method Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 67 days Incidence of Adverse Events (AEs) Up to 47 days Incidence of Serious Adverse Events (SAEs) Up to 74 days Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 67 days Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 67 days Incidence of clinically significant changes in vital signs: Body temperature Up to 74 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 74 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 74 days Incidence of clinically significant changes in vital signs: Heart rate Up to 74 days Incidence of clinically significant changes in 12-Lead electrocardiogram (ECG) parameters Up to 74 days
Trial Locations
- Locations (1)
ICON (LPRA) - Salt Lake
🇺🇸Salt Lake City, Utah, United States