WCCT Global
Cypress, California, 90630, United States
Completed
NCT Number: NCT03198182
A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects
The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body
Completed
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Notify MeKey information
Conditions
Age range
21 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
DrugSpecified dose on specified days
BMS-986036
DrugSpecified dose on specified days
Primary outcomes
-
Incidence of adverse events (AEs)
Time frame: Up to 42 days
Safety
-
Incidence of serious adverse events (SAEs)
Time frame: Up to 42 days
Safety
Sponsors and collaborators
Lead sponsor
Bristol-Myers Squibb
Industry
Registry information
Official study title
A Randomized, Parallel, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 in Healthy Japanese and Non-Japanese Subjects
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 26, 2017
- Registry last updated
- May 1, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.