A Study of BMS-986195 in Healthy Male Subjects

• Status: Completed
• Trial end date: 2017-10-05
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Branebrutinib

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Male subjects, if not surgically sterilized, must agree to use adequate contraception

• Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight [kg]/[height (m)]2), and total body weight >50 kg

• All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center

• All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center

• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center

• Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator

Exclusion Criteria:

• Previous participation in the current study

• Known previous exposure to BMS-986195

• Employee of PRA or the Sponsor

• History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products

• Using tobacco products within 60 days prior to drug administration

• Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies

Other protocol defined inclusion/exclusion criteria could apply