A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Part of paid clinical trials in Miami Lakes, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06352528
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers
  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.

Key Dates

Start date
Apr 29, 2024
Status verified
Sep 2025
Primary completion
Sep 16, 2025
Completion
Sep 16, 2025

Study Design

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

Arms

  • Experimental: Group 1: Moderate Hepatic Impairment
  • Experimental: Group 2: Severe Hepatic Impairment
  • Experimental: Group 3: Normal Hepatic Function

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Days 1 to 11 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Panax Clinical ResearchMiami LakesFlorida33014-2811-
Orlando Clinical Research CenterOrlandoFlorida32809-3017-
The Texas Liver Institute, Inc.San AntonioTexas78215-

Find similar trials in Miami Lakes, FL

By research site
Panax Clinical Research· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLThe Texas Liver Institute, Inc.· San Antonio, TX

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