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OpenTrials
Completed

NCT Number: NCT04493567

Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

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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, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
  • Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI > 30 kg/m2 to ≤ 40 kg/m2
  • Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • Inability to tolerate subcutaneous (SC) injections
  • Inability to be venipunctured and/or tolerate venous access
  • Any sound medical, psychiatric, and/or social reason as determined by the investigator

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986036

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Up to 29 days

  2. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to 29 days

  3. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036

    Time frame: Up to 29 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 115 days

  2. Incidence of clinically significant changes in clinical laboratory results: Hematology tests

    Time frame: Up to 85 days

  3. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

    Time frame: Up to 85 days

  4. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

    Time frame: Up to 85 days

  5. Incidence of clinically significant changes in vital signs: Body temperature

    Time frame: Up to 85 days

  6. Incidence of clinically significant changes in vital signs: Respiratory rate

    Time frame: Up to 85 days

  7. Incidence of clinically significant changes in vital signs: Blood pressure

    Time frame: Up to 85 days

  8. Incidence of clinically significant changes in vital signs: Heart rate

    Time frame: Up to 85 days

  9. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

    Time frame: Up to 85 days

    The PR interval is the time from the onset of the P wave to the start of the QRS complex.

  10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval

    Time frame: Up to 85 days

    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

  11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval

    Time frame: Up to 85 days

    The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave

  12. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval

    Time frame: Up to 85 days

    Corrected QT interval using Fridericia's formula (QTcF)

  13. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 85 days

  14. Number of participants with local injection site reactions

    Time frame: Up to 57 days

  15. Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)

    Time frame: Up to 57 days

  16. Number of participants with Antibodies to BMS-986036

    Time frame: Up to 57 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 30, 2020
Registry last updated
Mar 18, 2022

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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