NCT06363630

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

Name: Clinical Trial NCT06363630
Creator: Celgene
Keywords: Healthy Volunteers, Itraconazole, Phase 1, drug, clinical trial, United States of America

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

Celgene·Phase 1·ClinicalTrials.gov·drugRecruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Healthy Volunteers
Drug/Device/Intervention: Itraconazole
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Celgene
Location: Atlanta,Lenexa, United States of America

Timeline & enrollment

Phase: Phase 1
Start date: Apr 23, 2024
End date: Aug 19, 2024
Enrollment: 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 personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06363630
Type: Non-Device Trial

About this record

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.