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

Phase 1

Completed

• Conditions: Nonalcoholic Fatty Liver Disease; Hepatic Cirrhosis; Liver Fibrosis; Nonalcoholic Steatohepatitis
• Interventions: Drug: BMS-986036

• Registration Number: NCT03445208
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-26
• Primary Completion: 2018-05-02
• Study Completion: 2018-05-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 3	BMS-986036	BMI \>30.0 ≤ 40.0
Cohort 1	BMS-986036	BMI 18.0 to ≤ 25.0
Cohort 2	BMS-986036	BMI \>25.0 to ≤ 30.0

Primary Outcome Measures

Name	Time	Method
Maximum observed serum concentration (Cmax)	29 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]	29 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]	29 days
Time of maximum observed serum concentration (Tmax)	29 days

Secondary Outcome Measures

Name	Time	Method
Number of adverse events (AE)	Up to 78 days
Serum biomarker antibody concentration	Up to 78 days
Number of injection site reactions	Up to 78 days
Number of serious adverse events (SAE)	Up to 78 days
Number of AEs leading to discontinuation	Up to 78 days
Number of deaths	Up to 78 days

Trial Locations

Locations (1)

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States