Recruiting
Phase 1

Vorasi­denib

Sponsor:

Institut de Recherches Internationales Servier (I.R.I.S.)

Code:

NCT07250633

Conditions

Severe Hepatic Impairment

Normal Hepatic Function

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Vorasidenib 20mg

Study Details

Brief 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

Study ID

NCT07250633

Start date

Apr 23, 2026

Status verified date

Jun, 2026

Completion date

Nov 23, 2026

Anticipated

Primary completion date

Nov 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Participants with hepatic impairment:

  • Diagnosis of cirrhosis due to parenchymal liver disease
  • Considered to have a Child-Pugh score of 10 to 15, consistent with severe HI, and a documented medical history of liver disease. Participants must be clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to screening and are likely to remain stable throughout the study.
  • Grade 0 or Grade 1 hepatic encephalopathy considered stable per Investigator assessment without exacerbation within the 6 months prior to screening.
  • Currently on a stable medication regimen, defined as not starting new drug(s) or significantly changing drug dosage(s) within 14 days preceding Day 1.
  • Non-hepatic abnormal laboratory values must be not clinically significant as judged by the Investigator (or designee) and the study medical monitor.
  • Anemia secondary to hepatic disease is acceptable if hemoglobin is ≥ 9 g/dL and anemia symptoms are not clinically significant. Platelet count must be ≥ 35,000 platelets.
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) of ≤ 480 msec.

Matched-control participants:

  • Healthy, with normal hepatic function with a Child-Pugh score below 5.
  • Resting blood pressure of 90 to 140 mmHg (systolic) and 40 to 90 mmHg (diastolic).
  • QTcF of ≤ 450 msec.
  • Participant must match hepatically impaired participants with respect to sex, race, age (±10 years), smoking status (smoke or vape ≤ 10 cigarettes/day), and body mass index (±20%).

Exclusion Criteria for all participants:

  • Women of childbearing potential (WOCBP) who are pregnant, lactating, or planning to become pregnant within 90 days after the dose of vorasidenib.
  • The participant is using hormonal contraceptives
  • Use of any other investigational drug or device within 30 days (or 5 half-lives if known, whichever is longer) before the dose of vorasidenib
  • Consumption of any nutrients known to modulate CYP450 enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, Seville \[blood\] orange products) within 14 days before vorasidenib administration.
  • Consumption of alcohol-containing foods or beverages or caffeine- or xanthine-containing foods or beverages (including, but not limited to, teas \[including decaffeinated teas\], coffees \[including decaffeinated coffees\], colas \[including decaffeinated colas\], energy drinks, gum containing caffeine, and chocolate (including foods and beverages containing chocolate) within 48 hours prior to admission
  • Any history (within 5 years prior to screening) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin
  • History within the previous 12 months of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 12 oz beer, 5 oz wine, or 1.5 oz spirits)
  • In the opinion of the Investigator, the participant is not suitable for entry into the study

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Participants with Severe Hepatic Impairment (HI)

experimental: Matched-Participants with Normal Hepatic Function

Interventions

Vorasidenib 20mg

Vorasidenib 20mg will be taken by mouth on Day 1

Primary outcome measure

  • Maximum observed plasma concentration (Cmax) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • AUC from time 0 extrapolated to infinity (AUC0-inf) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • Time to reach Cmax (Tmax) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • Apparent terminal elimination half-life (t1/2) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • Apparent oral clearance (CL/F) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • Apparent volume of distribution (Vz/F) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]
  • Apparent terminal elimination rate constant (Kel) [ Time Frame: Through the end of the treatment period (approximately 43 days) ]

Central Contacts and Locations

Central contacts

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

+33 1 55 72 60 00scientificinformation@servier.com

Locations

Arizona Clinical Trials

Recruiting

Chandler, Arizona, United States, 85225

Orlando Clinical Research Center

Recruiting

Orlando, Florida, United States, 32809

American Research Corporation

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Institut de Recherches Internationales Servier (I.R.I.S.)

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Institut de Recherches Internationales Servier (I.R.I.S.) on 2026-06-05.