Healthy Participants
Conditions
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
Interventions
DRUGBMS-986165
Single dose
DRUGFamotidine
Single dose
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
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Maximum observed plasma concentration (Cmax) 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 a 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 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of clinically significant changes in electrocardiogram (ECG) parameters | Up to 18 days |
| Incidence of Adverse Events (AEs) | Up to 39 days |
Countries
United States
Outcome results
None listed