Status:
COMPLETED
A Study of BMS-986195 in Healthy Male Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
August 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03245515
Start Date
August 15 2017
End Date
October 5 2017
Last Update
January 5 2018
Active Locations (1)
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1
Local Institution
Groningen, Netherlands, 9728 NZ