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

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ClinicalTrials.gov Identifier: NCT03445208
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatic Cirrhosis Liver Fibrosis Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Drug: BMS-986036 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : May 2, 2018
Actual Study Completion Date : May 2, 2018


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




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

Secondary Outcome Measures :
  1. Number of injection site reactions [ Time Frame: Up to 78 days ]
  2. Number of adverse events (AE) [ Time Frame: Up to 78 days ]
  3. Number of serious adverse events (SAE) [ Time Frame: Up to 78 days ]
  4. Number of AEs leading to discontinuation [ Time Frame: Up to 78 days ]
  5. Number of deaths [ Time Frame: Up to 78 days ]
  6. Serum biomarker antibody concentration [ Time Frame: Up to 78 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445208


Locations
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United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03445208     History of Changes
Other Study ID Numbers: MB130-070
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Liver Cirrhosis
Non-alcoholic Fatty Liver Disease
Digestive System Diseases