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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-28

Study Completion Date

2017-09-22

Brief Summary

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

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Detailed Description

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Conditions

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Metabolics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Module A

BMS-986036 Arm

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Specified dose on specified days

Module B

Placebo Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Specified dose on specified days

Interventions

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Placebo

Specified dose on specified days

Intervention Type DRUG

BMS-986036

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes