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

Primary Purpose

Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986036
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Cirrhosis

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

BMI 18.0 to ≤ 25.0

BMI >25.0 to ≤ 30.0

BMI >30.0 ≤ 40.0

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of injection site reactions
Number of adverse events (AE)
Number of serious adverse events (SAE)
Number of AEs leading to discontinuation
Number of deaths
Serum biomarker antibody concentration

Full Information

First Posted
February 20, 2018
Last Updated
March 17, 2020
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03445208
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
May 2, 2018 (Actual)
Study Completion Date
May 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
BMI 18.0 to ≤ 25.0
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
BMI >25.0 to ≤ 30.0
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
BMI >30.0 ≤ 40.0
Intervention Type
Drug
Intervention Name(s)
BMS-986036
Intervention Description
Crossover administration to abdomen then upper arm
Primary Outcome Measure Information:
Title
Maximum observed serum concentration (Cmax)
Time Frame
29 days
Title
Time of maximum observed serum concentration (Tmax)
Time Frame
29 days
Title
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)]
Time Frame
29 days
Title
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(0-inf)]
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Number of injection site reactions
Time Frame
Up to 78 days
Title
Number of adverse events (AE)
Time Frame
Up to 78 days
Title
Number of serious adverse events (SAE)
Time Frame
Up to 78 days
Title
Number of AEs leading to discontinuation
Time Frame
Up to 78 days
Title
Number of deaths
Time Frame
Up to 78 days
Title
Serum biomarker antibody concentration
Time Frame
Up to 78 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

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

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