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Completed

NCT Number: NCT04567667

Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance - Clinical Pharmacology Services - Madison

Madison, Wisconsin, 53704, 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

  • No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations
  • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height [m])2
  • Males must agree to follow specific methods of contraception, if applicable

Exclusion criteria

  • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
  • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment
  • Any major surgery within 6 weeks of study treatment administration

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

[14C] BMS-986278

Drug

Specified dose on specified days

Kinevac®

Drug

Specified dose on specified days

Other names: Sincalide

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986278

    Time frame: Up to 15 days

  2. Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)

    Time frame: Up to 15 days

  3. Time of maximum observed plasma concentration (Tmax) of BMS-986278

    Time frame: Up to 15 days

  4. Time of maximum observed plasma concentration (Tmax) of TRA

    Time frame: Up to 15 days

  5. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278

    Time frame: Up to 15 days

  6. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA

    Time frame: Up to 15 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 15 days

  2. Incidence of Serious Adverse Events (AEs)

    Time frame: Up to 73 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

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

    Time frame: Up to 43 days

    QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.

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

    Time frame: Up to 43 days

    The QT interval is the time from the start of the Q wave to the end of the T wave.

  12. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 43 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Pharmacokinetics and Metabolism of [14C] BMS-986278 in Healthy Male Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Jun 2, 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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