Hepatic ImpairmentPhase 1NCT05674474

A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function

A Phase 1 study testing Vorasidenib in people with Hepatic Impairment, run by Institut de Recherches Internationales Servier at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment
What is being tested?: Vorasidenib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: 14 Mar 2023to 18 Jul 2023
Phase: Phase 1
Are there results?: None posted in the registry

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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2).
Female participants of childbearing potential must use 2 effective methods of birth control during the study and for 90 days after the last dose of vorasidenib or be surgically sterile, or postmenopausal.
Male participants with female partners of childbearing potential must be sterile, or willing to use 2 effective methods of birth control from Screening until at least 90 days after the last dose of the study drug, or practice abstinence during the study.
Non-smoker or uses ≤10 cigarettes per day as judged by the investigator.
Agree to comply with all protocol requirements for the duration of the study.
Able to provide written informed consent prior to any procedure required by the study.

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Have normal hepatic function.
Inclusion Criteria for Participants with Hepatic Impairment Only:
Have chronic (more than 6 months) and stable hepatic impairment (i.e., no acute episodes of illness within 30 days before Screening due to deterioration of hepatic function) as assessed by a Child-Pugh classification score of moderate (7 to 9 points) and, if Stage 2 enrolls, mild (5 to 6 points).
The subject has grade 0 or grade 1 hepatic encephalopathy, considered stable per investigator assessment, without exacerbation within the 6 months prior to Screening.
The subject has a QTcF of ≤480 msec.

Who cannot join

Have a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
Have a history (within 5 years) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin.
The subject is a woman of childbearing potential who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug or the subject is on oral contraceptive pills within 14 days or 5 half-lives (whichever is longer) prior to the first dose administration and during the study.
Have received any vaccine or used any prescription (excluding hormone replacement therapy) or over-the-counter medications, including herbal or nutritional supplements, within 30 days before the first dose of the study drug.
Have a positive test result for hepatitis B surface antigen or antibodies to hepatitis C virus.
Have a positive test result for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

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Have a positive test result for human immunodeficiency virus (HIV) types 1 or 2 antibodies.
Have used strong or moderate CYP1A2 inhibitors and/or inducers within 14 days or 5 half-lives, whichever is longer, prior to the first dose administration. .
Have used any gastric acid reducing agents (eg, proton-pump inhibitors, H2-receptor antagonists, antacids) or drugs that can prolong the QT interval for 28 days or 5 drug half-lives (whichever is longer) prior to the first dosing and throughout the study
Have a history of severe and/or uncontrolled ventricular arrhythmias or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome).
Have a history of alcoholism or drug abuse within 3 months before Screening or excessive alcohol consumption.
Unable or unwilling to abstain from recreational drugs, alcohol, caffeine, xanthine-containing beverages or food (e.g., coffee, tea, chocolate, and caffeinated sodas, colas), grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 48 hours prior to study drug dosing until discharge.
Involved in strenuous activity (i.e., >30 minutes [min] per day) or contact sports within 48 hours of the first dose of the study drug or during the study.
Have a history of relevant drug and/or food allergies (i.e., allergy to drugs with the same class effect as vorasidenib or any excipients, or any significant food allergy).
Have received study drug in another investigational study within 30 days of dosing.
Exclusion Criteria for Participants with Hepatic Impairment Only:
Have ascites that requires paracentesis every 4 weeks or less frequently.
Have evidence of hepatorenal syndrome or hepatic encephalopathy.
Have a history of incipient/planned liver transplantation within 6 months of Screening or have received a liver transplant.
Have amylase and/or lipase levels ≥3 x upper limit of normal (ULN). Presence of 8 x ULN elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin and international normalized ratio (INR) of 3.5 for the hepatic impaired group.

Trial locations and contacts

1 site in 1 country.

United States1 site

American Research Corporation
San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a 20-mg Dose of Vorasidenib in Subjects With Moderate or Mild Hepatic Impairment and Matched Subjects With Normal Hepatic Function

Conditions: Hepatic Impairment
Being tested: Vorasidenib
Keywords: Vorasidenib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VorasidenibDrug
Also called S095032, AG-881
Administered orally as tablets.

Study groups in NCT05674474
Study group	Role	What they receive
Group A: Normal Hepatic Function	Experimental	Participants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Receives: Drug: Vorasidenib
Group B: Moderate or Mild Hepatic Impairment	Experimental	Stage 1: Participants with moderate hepatic impairment (Child-Pugh [C-P] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1. Receives: Drug: Vorasidenib

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) for Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

Secondary outcomes (15)

Apparent Terminal Elimination Half-life (t1/2) of Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Oral Clearance (CL/F) for Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Volume of Distribution (Vz/F) of Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Unbound Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t,u) for Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Unbound Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf,u) for Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Vorasidenib
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Cmax of Metabolite AGI-69460
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Tmax of Metabolite AGI-69460
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-t for Metabolite AGI-69460
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-inf for Metabolite AGI-69460
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Measured: Up to end of study [EOS] (up to approximately 29 days)
Number of Participants With Abnormalities in Laboratory Parameters
Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Measured: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in Vital Signs
Systolic and diastolic blood pressure, pulse rate, respiratory rate, and body temperature will be assessed.
Measured: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in 12-Lead Electrocardiogram (ECG) Results
Measured: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in Physical Examination Findings
Measured: Up to EOS (up to approximately 29 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 202318 Jul 2023

First posted6 Jan 2023
Study start14 Mar 2023
Primary completion18 Jul 2023
Study completion18 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05674474
Sponsor's protocol ID: PKH-95032-008
Status last verified: Feb 2024
First submitted: 30 Dec 2022
Last updated: 8 Feb 2024
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a 20-mg Dose of Vorasidenib in Subjects With Moderate or Mild Hepatic Impairment and Matched Subjects With Normal Hepatic Function
ClinicalTrials.gov ID: NCT05674474
Acronym / sponsor ID: PKH-95032-008
Conditions: Hepatic Impairment
Keywords: Vorasidenib
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Institut de Recherches Internationales ServierUniversity, hospital or other
Study start: 14 Mar 2023 (actual)
Primary completion: 18 Jul 2023 (actual)
Study completion: 18 Jul 2023 (actual)
First posted: 6 Jan 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A: Normal Hepatic Function	Experimental	Drug: VorasidenibParticipants with normal hepatic function will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1.
Group B: Moderate or Mild Hepatic Impairment	Experimental	Drug: VorasidenibStage 1: Participants with moderate hepatic impairment (Child-Pugh [C-P] Class B, score of 7 to 9) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2: Participants with mild hepatic impairment (C-P Class A, score of 5 to 6) will receive a single oral dose of 20 mg (2 × 10 mg) vorasidenib tablets on Day 1. Stage 2 will be conducted if a clinically meaningful increase in exposure of vorasidenib is observed in participants with moderate hepatic impairment in Stage 1.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Have a body mass index of 18 to 40 kilograms per square meter (kg/m^2).
Female participants of childbearing potential must use 2 effective methods of birth control during the study and for 90 days after the last dose of vorasidenib or be surgically sterile, or postmenopausal.
Male participants with female partners of childbearing potential must be sterile, or willing to use 2 effective methods of birth control from Screening until at least 90 days after the last dose of the study drug, or practice abstinence during the study.
Non-smoker or uses ≤10 cigarettes per day as judged by the investigator.
Agree to comply with all protocol requirements for the duration of the study.

Key exclusion criteria (20 listed)

Have a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
Have a history (within 5 years) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin.
The subject is a woman of childbearing potential who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug or the subject is on oral contraceptive pills within 14 days or 5 half-lives (whichever is longer) prior to the first dose administration and during the study.
Have received any vaccine or used any prescription (excluding hormone replacement therapy) or over-the-counter medications, including herbal or nutritional supplements, within 30 days before the first dose of the study drug.
Have a positive test result for hepatitis B surface antigen or antibodies to hepatitis C virus.

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
VorasidenibAlso: S095032, AG-881Administered orally as tablets.	Drug	Group A: Normal Hepatic Function, Group B: Moderate or Mild Hepatic Impairment

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC From Time 0 Extrapolated to Infinity (AUC0-inf) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose

15 secondary outcomes

Apparent Terminal Elimination Half-life (t1/2) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Oral Clearance (CL/F) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Apparent Volume of Distribution (Vz/F) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Unbound Plasma Concentration Versus Time Curve From Time 0 to the Last Quantifiable Concentration (AUC0-t,u) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area Under the Unbound Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf,u) for Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Vorasidenib
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Cmax of Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Tmax of Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-t for Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-inf for Metabolite AGI-69460
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Number of Participants With Adverse Events (AEs)
Time frame: Up to end of study [EOS] (up to approximately 29 days)
Number of Participants With Abnormalities in Laboratory Parameters
Time frame: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in Vital Signs
Time frame: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in 12-Lead Electrocardiogram (ECG) Results
Time frame: Up to EOS (up to approximately 29 days)
Number of Participants With Abnormalities in Physical Examination Findings
Time frame: Up to EOS (up to approximately 29 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site 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 in people with Hepatic Impairment, run by Institut de Recherches Internationales Servier at 1 site 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 11 inclusion and 20 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: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Vorasidenib (time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05674474.

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 8 Feb 2024.