Severe Hepatic ImpairmentPhase 1NCT07250633
Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-Control Participants
A Phase 1 study testing Vorasidenib 20mg in people with Severe Hepatic Impairment and Normal Hepatic Function, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Hepatic Impairment, Normal Hepatic Function
- What is being tested?
- Vorasidenib 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Apr 2026to 23 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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%).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department contact
United States3 sites, 3 recruiting
- Recruiting
Arizona Clinical Trials
Chandler, Arizona, 85225
Dr. Anita Kohli
- Recruiting
Orlando Clinical Research Center
Orlando, Florida, 32809
Dr. Thomas Marbury
- Recruiting
American Research Corporation
San Antonio, Texas, 78215
Dr. Eric Lawitz
About this study
Official title: 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
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
- Being tested
- Vorasidenib 20mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vorasidenib 20mgDrug
Vorasidenib 20mg will be taken by mouth on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Participants with Severe Hepatic Impairment (HI) | Experimental | Not described Receives: Drug: Vorasidenib 20mg |
| Matched-Participants with Normal Hepatic Function | Experimental | Not described Receives: Drug: Vorasidenib 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: 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)
Measured: Through the end of the treatment period (approximately 43 days)
AUC from time 0 extrapolated to infinity (AUC0-inf)
Measured: Through the end of the treatment period (approximately 43 days)
Time to reach Cmax (Tmax)
Measured: Through the end of the treatment period (approximately 43 days)
Apparent terminal elimination half-life (t1/2)
Measured: Through the end of the treatment period (approximately 43 days)
Apparent oral clearance (CL/F)
Measured: Through the end of the treatment period (approximately 43 days)
Apparent volume of distribution (Vz/F)
Measured: Through the end of the treatment period (approximately 43 days)
Apparent terminal elimination rate constant (Kel)
Measured: Through the end of the treatment period (approximately 43 days)
Secondary outcomes (2)
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Through the end of the study (approximately 50 days)
Number of participants experiencing clinically significant changes in laboratory assessments, vital signs, ECG results, or physical examination findings
Measured: Through the end of the study (approximately 50 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start23 Apr 2026
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Hepatic ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250633
- Sponsor's protocol ID
- S95032-223
- Status last verified
- Jun 2026
- First submitted
- 18 Nov 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07250633
- Acronym / sponsor ID
- S95032-223
- Conditions
- Severe Hepatic Impairment, Normal Hepatic Function
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Severe Hepatic Impairment (HI) | Experimental | Drug: Vorasidenib 20mg |
| Matched-Participants with Normal Hepatic Function | Experimental | Drug: Vorasidenib 20mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vorasidenib 20mgVorasidenib 20mg will be taken by mouth on Day 1 | Drug | Matched-Participants with Normal Hepatic Function, Participants with Severe Hepatic Impairment (HI) |
Primary outcome
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)
2 secondary outcomes
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Through the end of the study (approximately 50 days)
Number of participants experiencing clinically significant changes in laboratory assessments, vital signs, ECG results, or physical examination findings
Time frame: Through the end of the study (approximately 50 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vorasidenib 20mg in people with Severe Hepatic Impairment and Normal Hepatic Function, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department (+33 1 55 72 60 00, scientificinformation@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Through the end of the treatment period (approximately 43 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.