A Study of Mezigdomide in Healthy Participants and Participants With Hepatic Impairment

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT05707390
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The aim of this study is to measure the concentration levels of mezigdomide in the blood of participants with mild, moderate, and severe hepatic impairment, and in matched healthy control participants with normal hepatic function.

Key Dates

Start date
Feb 20, 2023
Status verified
Feb 2024
Primary completion
Sep 13, 2023
Completion
Sep 13, 2023

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mild hepatic impairment
  • Experimental: Moderate hepatic impairment
  • Experimental: Severe hepatic impairment
  • Experimental: Healthy participants

Primary Outcome Measure

Maximum observed concentration (Cmax) [ Time Frame: Up to 6 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
PANAXMiami LakesFlorida33014-
Orlando Clinical Research Center OCRCOrlandoFlorida32809-
The Texas Liver InstituteSan AntonioTexas78215-

Find similar trials in Miami Lakes, FL

By research site
PANAX· Miami Lakes, FLOrlando Clinical Research Center OCRC· Orlando, FLThe Texas Liver Institute· San Antonio, TX

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