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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 - Trial NCT06363630

Access comprehensive clinical trial information for NCT06363630 through Pure Global AI's free database. This Phase 1 trial is sponsored by Celgene and is currently Recruiting. The study focuses on Healthy Volunteers. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06363630
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06363630
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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
A Phase 1, Open-label, 2-part, 2-period, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of Golcadomide (BMS-986369) in Healthy Participants

Study Focus

Healthy Volunteers

Itraconazole

Interventional

drug

Sponsor & Location

Celgene

Atlanta,Lenexa, United States of America

Timeline & Enrollment

Phase 1

Apr 23, 2024

Aug 19, 2024

36 participants

Primary Outcome

Maximum observed plasma concentration (Cmax),Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)),Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Summary

The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of
 coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.

ICD-10 Classifications

Healthy person accompanying sick person
Routine general health check-up of armed forces
Routine general health check-up of sports teams
Routine general health check-up of inhabitants of institutions

Data Source

ClinicalTrials.gov

NCT06363630

Non-Device Trial