Clinical Trials Directory

Trials / Completed

CompletedNCT06363630

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Celgene · Industry
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGItraconazoleSpecified dose on specified days.
DRUGRifampinSpecified dose on specified days
DRUGGolcadomideSpecified dose on specified days

Timeline

Start date
2024-04-23
Primary completion
2024-08-29
Completion
2024-08-29
First posted
2024-04-12
Last updated
2024-09-27

Locations

2 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06363630. Inclusion in this directory is not an endorsement.