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

Phase 1CompletedNCT04209699

Bristol-Myers Squibb18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

BMS-986165DRUG

Single dose

FamotidineDRUG

Single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PRA Health Sciences - Salt Lake

Salt Lake City, Utah, United States

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

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 a 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 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

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

Secondary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Up to 39 days

Number of clinically significant changes in vital sign measurements

Time frame: Up to 18 days

Data from ClinicalTrials.gov

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