Metabolics
Conditions
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
Interventions
DRUGPlacebo
Specified dose on specified days
DRUGBMS-986036
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 42 days | Safety |
| Incidence of serious adverse events (SAEs) | Up to 42 days | Safety |
Countries
United States
Outcome results
None listed