A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects
- Registration Number
- NCT03198182
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive
- Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for > 10 years, and both parents are ethnically Japanese)
Exclusion Criteria
- Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- Known or suspected autoimmune disorder, excluding vitiligo
Other protocol defined inclusion/exclusion criteria could apply
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Module B Placebo Placebo Arm Module A BMS-986036 BMS-986036 Arm
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs) Up to 42 days Safety
Incidence of serious adverse events (SAEs) Up to 42 days Safety
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
WCCT Global
🇺🇸Cypress, California, United States