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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Nonalcoholic Fatty Liver Disease; Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Steatohepatitis

Treatments: Drug: BMS-986036

Study type: Interventional

Funder types: Industry

Identifiers

NCT03445208

MB130-070

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Cohort 1

Experimental group

Description:

BMI 18.0 to ≤ 25.0

Treatment:

Drug: BMS-986036

Cohort 2

Experimental group

Description:

BMI \>25.0 to ≤ 30.0

Treatment:

Drug: BMS-986036

Cohort 3

Experimental group

Description:

BMI \>30.0 ≤ 40.0

Treatment:

Drug: BMS-986036