A Study to Evaluate the Drug Levels of Mezigdomide in Adult Participants With Renal Impairment

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Celgene
Study ID
NCT06318676
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 82 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to evaluate the drug levels of mezigdomide in participants with renal impairment.

Key Dates

Start date
Mar 21, 2024
Status verified
May 2025
Primary completion
Nov 15, 2024
Completion
Nov 15, 2024

Study Design

Enrollment
26 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: Participants with severe renal impairment
  • Experimental: Group B: Participants with End Stage Renal Disease
  • Experimental: Group C: Participants with normal renal function

Primary Outcome Measure

Maximum observed concentration (Cmax) [ Time Frame: Up to 24 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
PANAXMiami LakesFlorida33014-
Omega Research Group - OrlandoOrlandoFlorida32806-
Orlando Clinical Research Center OCRCOrlandoFlorida32809-

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