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
NCT06363630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2024-09-27
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
- Healthy Volunteers
Interventions
- DRUG
-
Itraconazole
Specified dose on specified days.
- DRUG
-
Specified dose on specified days
- DRUG
-
Golcadomide
Specified dose on specified days
Sponsors & Collaborators
-
Celgene
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-04-23
- Primary Completion
- 2024-08-29
- Completion
- 2024-08-29
- FDA Drug
- Yes
Countries
- United States
Study Locations
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