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Completed

NCT Number: NCT03445208

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

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

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Key information

Conditions

Hepatic Cirrhosis Digestive System Diseases Fatty Liver Fibrosis Liver Cirrhosis Liver Diseases Liver Fibrosis Non-alcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Salt Lake City, Utah, 84107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-986036

Drug

Crossover administration to abdomen then upper arm

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2018
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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