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

Brief Title

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

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

Brief Summary

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


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum observed serum concentration (Cmax)

Secondary Outcome

 Number of injection site reactions

Condition

Hepatic Cirrhosis

Intervention

BMS-986036

Study Arms / Comparison Groups

 Cohort 1
Description:  BMI 18.0 to ≤ 25.0

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

30

Start Date

February 14, 2018

Completion Date

May 2, 2018

Primary Completion Date

May 2, 2018

Eligibility 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
      

Gender

All

Ages

21 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Bristol-Myers Squibb, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03445208

Organization ID

MB130-070


Responsible Party

Sponsor

Study Sponsor

Bristol-Myers Squibb


Study Sponsor

Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb


Verification Date

March 2020