NCT07250633

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

A Phase 1, Open-Label, Non-randomized, Single Dose, Safety, Tolerability, and Pharmacokinetic Study of Vorasidenib Administered to Participants With Severe Hepatic Impairment and Matched-Participants With Normal Hepatic Function

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Institut de Recherches Internationales Servier (I.R.I.S.) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Severe Hepatic Impairment
• Normal Hepatic Function

Interventions

Type	Name	Description
DRUG	Vorasidenib 20mg	Vorasidenib 20mg will be taken by mouth on Day 1

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-11-26
• Last updated: 2025-11-26

Regulatory

• FDA-regulated drug study