Skip to main content
OpenTrials
Completed

NCT Number: NCT06227975

A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.

Completed

Looking for future studies?

Notify Me

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 as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
  • Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height[m])^2

Exclusion criteria

  • History of hypokalemia.
  • Any significant acute or chronic medical illness as determined by the investigator.
  • Participant has a history of syncope in the year prior to Day 1.

Other protocol-defined incusion/exclusion criteria apply.

Treatment and study plan

[14C]-BMS-986368

Drug

Specified dose on specified days

Other names: CC-97489

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 15

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

  4. Total Radioactivity (TRA)

    Time frame: Up to Day 30

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to Day 36

  2. Number of participants with Serious AEs (SAEs)

    Time frame: Up to Day 36

  3. Number of participants with AEs leading to discontinuation

    Time frame: Up to Day 36

  4. Number of participants with vital sign abnormalities

    Time frame: Up to Day 30

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to Day 30

  6. Number of participants with physical examination abnormalities

    Time frame: Up to Day 30

  7. Number of participants with clinical laboratory test abnormalities

    Time frame: Up to Day 30

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2024
Registry last updated
May 13, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.