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Part 1 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 69

Awards & highlights

Study Summary

This trial aims to see how taking itraconazole or rifampin along with golcadomide affects the levels of golcadomide in the body.

Who is the study for?

This trial is for healthy individuals who can safely take the medications involved. Specific eligibility details are not provided, but typically participants should have no significant health issues that could interfere with the study.Check my eligibility

What is being tested?

The study is testing how golcadomide levels change when taken with either itraconazole or rifampin. These drugs affect liver enzymes and could alter how golcadomide is processed in the body.See study design

What are the potential side effects?

Possible side effects may include reactions to itraconazole such as nausea, rash, or liver problems; rifampin might cause upset stomach or even flu-like symptoms; and golcadomide's side effects aren't specified here.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 69

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 69

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 69 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 plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

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

Maximum observed plasma concentration (Cmax)

Secondary outcome measures

Apparent terminal phase half-life (T-HALF)

Apparent total body clearance (CLT/F)

Apparent volume of distribution (Vz/F)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2Experimental Treatment2 Interventions

Group II: Part 1Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Itraconazole

2017

Completed Phase 2

~780

Rifampin

2011

Completed Phase 3

~2140

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor

637 Previous Clinical Trials

129,478 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,510 Previous Clinical Trials

3,371,089 Total Patients Enrolled

Frequently Asked Questions

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

Has Part 1 been officially endorsed by the FDA?

"Given that this is a Phase 1 trial, the safety rating for Part 1 is estimated to be at level 1. This indicates limited data supporting both safety and efficacy in this phase of the study."

Answered by AI

Are individuals older than 25 years being included in this research?

"Eligible candidates for this research must fall between the ages of 18 and 55. It is worth noting that there are a total of 71 trials targeting individuals under the age of 18, as well as 399 studies catering to those over the age of 65."

Answered by AI

Are there any available slots for new participants in this ongoing medical study?

"As per clinicaltrials.gov, this specific investigation is not actively seeking volunteers. The trial was initially uploaded on April 16th, 2024 and its latest update was on April 9th, 2024. Although this particular study isn't enrolling participants currently, there are a total of 867 other ongoing trials that are presently open for recruitment."

Answered by AI

Which group of individuals is more suitable to be enrolled in this research study?

"Candidates interested in enrolling in this research study must be healthy individuals aged between 18 and 55. A total of 36 participants will be accepted into the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants

2024. "A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06363630.