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Completed

NCT Number: NCT05284890

A Study to Evaluate the Drug Levels of [14C]CC-99677 in Healthy Male Participants

The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C] CC-99677.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male participants
  • Body mass index of 18.0 to 33.0 kg/m^2, inclusive

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Any major surgery within 4 weeks of intervention administration
  • History of any significant drug allergy

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

CC-99677

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum plasma concentration of the drug (Cmax) for CC-99677

    Time frame: Up to 15 days

  2. Time of maximum observed plasma concentration (Tmax) for CC-99677

    Time frame: Up to 15 days

  3. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) for CC-99677

    Time frame: Up to 15 days

  4. Total radioactivity recovered in urine (UR)

    Time frame: Up to 15 days

  5. Percent of total radioactivity recovered in urine (%UR)

    Time frame: Up to 15 days

  6. Total radioactivity recovered in feces (FR)

    Time frame: Up to 15 days

  7. Percent of total radioactivity recovered in feces (%FR)

    Time frame: Up to 15 days

  8. Total radioactivity recovered in bile (BR)

    Time frame: Up to 15 days

  9. Total radioactivity recovered in urine, feces, and bile combined (Rtotal)

    Time frame: Up to 15 days

  10. Percent of total radioactivity recovered in all excreta (%Total)

    Time frame: Up to 15 days

  11. Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA)

    Time frame: Up to 15 days

Secondary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: Up to 50 days

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 50 days

  3. Incidence of AEs leading to discontinuation

    Time frame: Up to 15 days

  4. Incidence of vital sign abnormalities

    Time frame: Up to 15 days

  5. Incidence of electrocardiogram (ECG) abnormalities

    Time frame: Up to 15 days

  6. Incidence of physical examination abnormalities

    Time frame: Up to 15 days

  7. Incidence of clinical laboratory test abnormalities

    Time frame: Up to 15 days

  8. Cmax

    Time frame: Up to 15 days

  9. Tmax

    Time frame: Up to 15 days

  10. AUC(0-T)

    Time frame: Up to 15 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 in Healthy Male Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Dec 1, 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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