A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers
- Registration Number
- NCT04209699
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
- All female subjects must have a negative serum or urine pregnancy test
Exclusion Criteria
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
- History of administration of live vaccines within 60 days before screening until clinic discharge
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
Other protocol-defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment A: BMS-986165 alone, fasted BMS-986165 - Treatment C: BMS-986165 with famotidine pretreatment, fasted BMS-986165 - Treatment B: BMS-986165 alone, fed BMS-986165 - Treatment C: BMS-986165 with famotidine pretreatment, fasted Famotidine -
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone Day 1 to Day 13 Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition Day 1 to Day 13 Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition Day 1 to Day 13 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone Day 1 to Day 13 Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone Day 1 to Day 13 Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition Day 1 to Day 13
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events (AEs) Up to 39 days Number of clinically significant changes in electrocardiogram (ECG) parameters Up to 18 days Number of clinically significant changes in vital sign measurements Up to 18 days Number of clinically significant changes in clinical laboratory test results Up to 18 days
Trial Locations
- Locations (1)
PRA Health Sciences - Salt Lake
🇺🇸Salt Lake City, Utah, United States