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

March 17, 2020 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • PRA Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
BMI 18.0 to ≤ 25.0
Drug: BMS-986036
Crossover administration to abdomen then upper arm
Experimental: Cohort 2
BMI >25.0 to ≤ 30.0
Drug: BMS-986036
Crossover administration to abdomen then upper arm
Experimental: Cohort 3
BMI >30.0 ≤ 40.0
Drug: BMS-986036
Crossover administration to abdomen then upper arm

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

May 2, 2018

Study Completion (Actual)

May 2, 2018

Study Registration Dates

First Submitted

February 20, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MB130-070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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