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

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID

NCT04209699

Run by

Bristol-Myers Squibb

People needed

18

Starts

2019-12-27

Expected to finish

2020-02-11

Last updated by the study team

2020-04-21

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PRA Health Sciences - Salt Lake — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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