A Study of BMS-986195 in Healthy Male Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: BMS-986195

Study type: Interventional

Funder types: Industry

Identifiers

NCT03245515

IM014-016

2017-002706-12 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

BMS-986195

Experimental group

Description:

A single oral solution dose of BMS-986195

Treatment:

Drug: BMS-986195