A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986165
* Drug: Famotidine


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A: BMS-986165 alone, fasted<br> | Drug: BMS-986165<br>* Single dose<br>|
| Experimental: Treatment B: BMS-986165 alone, fed<br> | Drug: BMS-986165<br>* Single dose<br>|
| Experimental: Treatment C: BMS-986165 with famotidine pretreatment, fasted<br> | Drug: BMS-986165<br>* Single dose<br>Drug: Famotidine<br>* Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 39 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 | 
| Number of clinically significant changes in electrocardiogram (ECG) parameters |  | Up to 18 days |