Overview

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

Status:
Completed
Trial end date:
2020-02-11
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
BMS-986165
Famotidine
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/exclusion criteria could apply