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

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.

NCT Number	NCT07250633
Lead Sponsor	Institut de Recherches Internationales Servier (I.R.I.S.)
Conditions	Severe Hepatic Impairment, Normal Hepatic Function
Enrollment	20 participants
Start Date	2026-04-23
Primary Completion	2026-11-23 (estimated)
Study Completion	2026-11-23 (estimated)
Updated on ClinicalTrials.gov	2026-06-05