Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants

Conditions

• Normal Hepatic Function
• Severe Hepatic Impairment

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• Vorasidenib 20mg — DRUG
  Vorasidenib 20mg will be taken by mouth on Day 1

Study Details

The objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of one dose of vorasidenib in participants with severe impaired hepatic function compared to participants with normal hepatic function. The study includes a screening phase, a treatment period, and a follow-up period. During the first part of the treatment period, from Day 1 through Day 4, participants will remain in-house in the clinical research unit. In the second part of the treatment period, from Day 5 through Day 43, participants can go home but may also choose to remain in-house. The entire study, including screening and follow-up, will last up to 77 days. Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), vital sign checks, and physical exams.

Key Dates

Start date

Apr 23, 2026

Status verified

Jun 2026

Primary completion

Nov 23, 2026

Completion

Nov 23, 2026

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Participants with Severe Hepatic Impairment (HI)
• Experimental: Matched-Participants with Normal Hepatic Function

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]

Central Contacts

• Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
  +33 1 55 72 60 00
  [email protected]

Locations (3)

Find similar trials in Chandler, AZ