A Study of Experimental Medication BMS-986036 Given to Healthy Participants

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2018-05-02

Brief Summary

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This is a study of experimental medication BMS-986036 given to healthy participants.

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Detailed Description

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Conditions

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Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

BMI 18.0 to ≤ 25.0

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Crossover administration to abdomen then upper arm

Cohort 2

BMI \>25.0 to ≤ 30.0

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Crossover administration to abdomen then upper arm

Cohort 3

BMI \>30.0 ≤ 40.0

Group Type EXPERIMENTAL

BMS-986036

Intervention Type DRUG

Crossover administration to abdomen then upper arm

Interventions

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BMS-986036

Crossover administration to abdomen then upper arm

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* BMI of 18 to ≤ 40 kg/m2

Exclusion Criteria

* Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
* Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Known or suspected autoimmune disorder, excluding vitiligo
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 6 weeks of study drug administration
* History of diabetes mellitus

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes