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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Celgene
Study ID
NCT06363630
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Itraconazole — DRUG
    Specified dose on specified days.
  • Rifampin — DRUG
    Specified dose on specified days
  • Golcadomide — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

First listed
Apr 12, 2024
Start date
Apr 23, 2024
Status verified
Sep 2024
Primary completion
Aug 29, 2024
Completion
Aug 29, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1
  • Experimental: Part 2

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Up to Day 67 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Local Institution - 0002AtlantaGeorgia30331-
Local Institution - 0001LenexaKansas66219-

Find similar trials in Atlanta, GA

By research site
Local Institution - 0002· Atlanta, GALocal Institution - 0001· Lenexa, KS

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