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[14C]-BMS-986368 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 36
Awards & highlights

Study Summary

This trial aims to understand how BMS-986368 is processed and eliminated from the body in healthy male participants.

Who is the study for?
This trial is for healthy male participants with no significant medical issues, a normal physical exam, and a body mass index (BMI) between 18.0 to 35.0 kg/m2. They must not have had low potassium levels or any serious illness recently, nor a history of fainting in the past year.Check my eligibility
What is being tested?
The study is looking at how an orally administered drug called [14C]-BMS-986368 is absorbed, processed by the body, and eliminated in healthy men. It will track the drug's journey through the body and measure what happens to it.See study design
What are the potential side effects?
Since this trial involves healthy volunteers and focuses on pharmacokinetics rather than treatment effects, specific side effects are not listed but may include typical reactions to medication such as digestive discomfort or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Maximum observed concentration (Cmax)
Time of maximum observed concentration (Tmax)
+1 more
Secondary outcome measures
Number of participants with AEs leading to discontinuation
Number of participants with Adverse Events (AEs)
Number of participants with Serious AEs (SAEs)
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [14C]-BMS-986368Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[14C]-BMS-986368
2024
Completed Phase 1
~10

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor
642 Previous Clinical Trials
130,565 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,519 Previous Clinical Trials
3,372,181 Total Patients Enrolled
~5 spots leftby Jun 2025
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