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

Liver Fibrosis Clinical Trial

Official title:

An Open-Label, Single-Dose, Fixed-Sequence Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986036 Administered to the Abdomen and Upper Arm in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445208
• Other study ID #: MB130-070
• Status: Completed
• Phase: Phase 1
• Start date: February 14, 2018
• Est. completion date: May 2, 2018

Study information

• Verified date: March 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Cirrhosis
• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• BMS-986036
Crossover administration to abdomen then upper arm

Locations

Country	Name	City	State
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed serum concentration (Cmax)		29 days
Primary	Time of maximum observed serum concentration (Tmax)		29 days
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]		29 days
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]		29 days
Secondary	Number of injection site reactions		Up to 78 days
Secondary	Number of adverse events (AE)		Up to 78 days
Secondary	Number of serious adverse events (SAE)		Up to 78 days
Secondary	Number of AEs leading to discontinuation		Up to 78 days
Secondary	Number of deaths		Up to 78 days
Secondary	Serum biomarker antibody concentration		Up to 78 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form