An Open-label 3×3 Cross-over Study to Compare Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of Single Doses of BMS-986165 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- BMS-986165
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Treatment A: BMS-986165 alone, fasted
Intervention: BMS-986165
Treatment B: BMS-986165 alone, fed
Intervention: BMS-986165
Treatment C: BMS-986165 with famotidine pretreatment, fasted
Intervention: BMS-986165
Treatment C: BMS-986165 with famotidine pretreatment, fasted
Intervention: Famotidine
Outcomes
Primary Outcomes
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 to Day 13
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Time Frame: 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
Time Frame: 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
Time Frame: Day 1 to Day 13
Secondary Outcomes
- 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)