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[14C]-BMS-986368 for Healthy Subjects

Phase 1

Recruiting

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 36

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

Do I qualify?Apply below to find out

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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

636 Previous Clinical Trials

128,963 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,989 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being enrolled in this ongoing clinical trial?

"Based on the information provided by clinicaltrials.gov, this particular clinical trial is not actively seeking patients at this time. The trial was first made available for enrollment on February 2nd, 2024 and has been last updated on January 19th, 2024. It's important to note that despite this trial not being open for recruitment currently, there are still a total of 778 other ongoing trials that are actively enrolling participants."

Answered by AI

What are the eligibility criteria for participating in this clinical trial?

"In order to qualify for participation in this trial, candidates must be healthy individuals between the ages of 18 and 55. The study aims to recruit approximately 8 participants."

Answered by AI

Can individuals below the age of 75 participate in this clinical investigation?

"This clinical trial is seeking individuals who are above 18 years old and under the age of 55."

Answered by AI

What level of risk does [14C]-BMS-986368 pose to patients?

"Due to the limited data supporting safety and efficacy, [14C]-BMS-986368 is assigned a safety rating of 1 on a scale from 1 to 3 by our team at Power. This determination aligns with its Phase 1 trial status."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06227975.

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