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OpenTrials
Completed

NCT Number: NCT03210909

Pharmacokinetics and Metabolism of [14C] BMS-986231 in Healthy Male Participants

An intravenous infusion in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986231

Completed

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Key information

Conditions

Heart Decompensation, Acute Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed Informed Consent
  • Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests
  • Body weight between 75 and 95 kg, inclusive; body mass index (BMI) between 18 to 32 kg/m2.

Exclusion criteria

  • History of chronic illness
  • Chronic headaches
  • Recurrent dizziness
  • Personal or family history of heart disease
  • Personal history of bleeding diathesis

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

BMS-986231

Drug

BMS-986231

Primary outcomes

  1. Area Under the Concentration-Time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])

    Time frame: Up to 8 days

    Measured by plasma concentrations

  2. Percent of Total Radioactivity Recovered in All Excreta (% total)

    Time frame: Up to 8 days

    Measured by plasma urine, feces, and vomit (if applicable) volumes and radioactivity counts

  3. Half-Life (T-HALF)

    Time frame: Up to 8 days

    Measured by plasma concentrations

  4. Total Body Clearance (CLT)

    Time frame: Up to 8 days

    Measured by plasma concentrations

  5. Volume of Distribution during Terminal Elimination Phase (Vz/F)

    Time frame: Up to 8 days

    Measured by plasma concentrations

  6. Time to Maximum Observed Concentration (Tmax)

    Time frame: Up to 8 days

    Measured by plasma concentrations

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 8 days

    Measured by investigator assessment

  2. Results of electrocardiogram tests (ECGs)

    Time frame: Up to 8 days

    Measured by investigator assessment

  3. Results of vital sign measurements

    Time frame: Up to 8 days

    Measured by investigator assessment

  4. Results of clinical laboratory tests

    Time frame: Up to 8 days

    Measured by investigator assessment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 7, 2017
Registry last updated
Aug 1, 2017

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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