A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT05674474
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.

Key Dates

Start date
Mar 14, 2023
Status verified
Feb 2024
Primary completion
Jul 18, 2023
Completion
Jul 18, 2023

Study Design

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

Arms

  • Experimental: Group A: Normal Hepatic Function
    Participants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.
  • Experimental: Group B: Moderate or Mild Hepatic Impairment
    Stage 1: Participants with moderate hepatic impairment (Child-Pugh \[C-P\] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Vorasidenib [ Time Frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
American Research CorporationSan AntonioTexas78215-

Find similar trials in San Antonio, TX

By research site
American Research Corporation· San Antonio, TX

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