A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Metabolics

Treatments: Drug: Placebo; Drug: BMS-986036

Study type: Interventional

Funder types: Industry

Identifiers

NCT03198182

MB130-057

Details and patient eligibility

About

The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body

Enrollment: 63 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Module A

Experimental group

Description:

BMS-986036 Arm

Treatment:

Drug: BMS-986036

Module B

Placebo Comparator group

Description:

Placebo Arm

Treatment:

Drug: Placebo