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Completed

NCT Number: NCT04269356

Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance - Clinical Pharmacology Services - Madison

Madison, Wisconsin, 53704, United States

About this study

Recruitment temporarily on hold due to COVID-19.

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 participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.
  • Males must agree to follow specific methods of contraception, if applicable, while participating in the trial

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
  • History of any significant drug and/or food allergies

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986256

Drug

Specified dose on specified days

Milk of magnesia

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of [14C] BMS-986256

    Time frame: Up to 49 days

  2. Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256

    Time frame: Up to 49 days

  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256

    Time frame: Up to 49 days

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 49 days

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

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

    Time frame: Up to 49 days

  11. Incidence of clinically significant changes in physical examination findings

    Time frame: Up to 49 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2020
Registry last updated
Jan 10, 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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