Hepatic ImpairmentPhase 1NCT06908954
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
A Phase 1 study testing Palovarotene in people with Hepatic Impairment and Healthy, run by Ipsen at 4 sites in United States.
Trial summary
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver 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, Healthy
- What is being tested?
- Palovarotene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Mar 2025to 6 Feb 2026
- 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
- Male and female participants must be 18 to 70 years of age (inclusive) at the time of signing informed consent.
- Body weight at least 60.0 kg with body mass index (BMI) within the range of 18.0 and 36.0 kg/m² (inclusive), at screening. BMI of >36.0 to ≤40.0 may be eligible if participant has moderate ascites scoring 3 points on the C-P criteria.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials
- Clinical diagnosis of chronic hepatic disease (stable for more than 3 months) with a documented history of underlying hepatic insufficiency and no acute episodes of illness within 30 days prior to Day -1 (admission) and no significant change in disease status (i.e. up to 1 point in the C-P classification) from screening to Day -1.
- A stable medication regimen, defined as not starting new therapy(ies) or significant changing dosage(s) within 30 days prior to dosing.
Who cannot join
- Presence or significant history of cardiovascular, respiratory, hepatic (except for the hepatic impairment for those concerned), renal, gastrointestinal, biliary, mucocutaneous, endocrinological, haematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Lymphoma, leukaemia or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Use of any medications (prescription or over the counter), herbal tea, energy drinks (including natural stimulants), herbal products (e.g. St. John's wort, garlic, milk thistle) or supplements/supratherapeutic doses of vitamins within 14 days prior to Day 1 and through discharge, apart from those approved by the investigator and the sponsor's medical monitor. Those with hepatic impairment may take concomitant medications
- Use of any medications that are moderate or strong inhibitors or inducers of CYP3A4
- Donation or loss (excluding volume drawn at screening or during menses) of more than 250 mL of blood or blood product within 3 months prior to screening. In addition, plan of blood donation within 8 weeks after the last PK sampling.
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- Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to the dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.
- Positive hepatitis C RNA test result at screening or within 3 months prior to the dose of study intervention. Note: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing.
- Sensitivity to the study intervention, or components thereof (including inactive ingredients), or drug or other allergy that, in the opinion of the investigator (or medical monitor), contraindicates participation in the study
- Evidence of relevant active disease at screening, including gastroenterological (other than hepatic cirrhosis), cardiac (e.g. myocardial infarction in the past year, angina or congestive heart failure), renal, respiratory, haematological, neuropsychiatric or neoplastic (basal or squamous cell skin cancer is acceptable) disease.
- Acute hepatitis B (positive for HBsAg) or acute hepatitis C (positive for anti-hepatitis C virus (HCV) for a duration of less than 6 months). Note: Participants with chronic HCV (positive for HCV RNA or anti-HCV for more than 6 months) are eligible for enrolment, if stable, as assessed by the investigator.
- Primary sclerosing cholangitis or preliminary diagnosed biliary obstruction at screening.
- Current or chronic history of liver disease. This includes (but is not limited to hepatitis virus infections), drug- or alcohol-related liver disease, non-alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ERG - Clinical Pharmacology of Miami
Miami, Florida, 33172
Orlando Clinical Research Center
Orlando, Florida, 32809
American Research Corporation/Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research
San Antonio, Texas, 78229
About this study
Official title: A Phase I, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Palovarotene in Male and Female Participants With Moderate and Severe Hepatic Impairment and Matched Participants With Normal Hepatic Function
The main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function.
The study will also assess the safety and tolerability of the single dose of palovarotene.
Read more
Participants will be enrolled in stages and divided into three groups based on their liver function:
- Group 1: Healthy participants with normal liver function
- Group 2: Participants with moderate liver impairment
- Group 3: Participants with severe liver impairment (only enrolled if Group 2 results are safe and acceptable)
Blood samples will be taken to assess how the drug binds to proteins in the blood. Participants will undergo various safety checks and procedures. Participants will stay in the clinical unit until Day 5 for these assessments and will return on Day 10 for a final visit.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- Palovarotene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalovaroteneDrug
A single dose of maximum 10 mg of palovarotene will be administered orally on Day 1 to healthy control participants with normal hepatic function
PalovaroteneDrug
A single 10 mg dose of palovarotene will be administered orally on Day 1 to Moderate hepatic impaired participants (Child-Pugh class B)
PalovaroteneDrug
A single 10 mg dose of either 5 mg or 10 mg of palovarotene will be administered orally on Day 1 to Severe hepatic impaired participants (Child-Pugh class C).
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Healthy participants | Experimental | Evaluation of the pharmacokinetics of IPN60120 in control healthy participants matching the age, sex and weight with hepatic impaired participants Receives: Drug: Palovarotene |
| Group 2 Moderate Hepatic impaired participants | Experimental | Evaluation of the pharmacokinetics of IPN60120 in Moderate Hepatic impaired participants (Child-Pugh class B) Receives: Drug: Palovarotene |
| Group 3 Severe Hepatic impaired participants | Experimental | Evaluation of the pharmacokinetics of IPN60120 in Severe Hepatic impaired participants (Child-Pugh class C) Receives: Drug: Palovarotene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma drug concentration (Cmax)
Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 hours after dosing
Measured: Over 96 hours postdose
Unbound fraction of drug in plasma (fu)
Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 h after dosing
Measured: Over 96 hours postdose
Time to maximum observed plasma concentration (Tmax)
Measure of AUC from time 0 to infinity (AUC0-∞) (total and unbound)
Measured: Over 96 hours postdose
Area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUC0-∞)
Measure of AUC from time 0 to infinity (AUC0-∞) (total and unbound)
Measured: Over 96 hours postdose
AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast)
Measure of AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast) (total and unbound)
Measured: Over 96 hours postdose
Apparent terminal elimination half life (T1/2)
Measure of apparent terminal elimination half-life over 96 hours post-dose
Measured: Over 96 hours postdose
Apparent terminal elimination rate constant (λz).
Measure of apparent terminal elimination rate constant (λz) over 96 hours post-dose
Measured: Over 96 hours postdose
Secondary outcomes (5)
Percentage of participants with Adverse Events (AEs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: From Baseline to Day 10
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Clinically significant change in laboratory parameters will be reported. The clinical significance will graded by the investigator.
Measured: At Day 2, Day 5 and Day 10
Percentage of participants with clinically significant change from baseline in physical examinations
Clinically significant changes in physical examinations will be reported. The clinical significance will be graded by the investigator.
Measured: At Day 1, 2 and 3, Day 5 and Day 10
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Measured: At Day 1, 2 and 3, Day 5 and Day 10
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings
Measured: At Day 1, 2 and 3, Day 5 and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start14 Mar 2025
- Primary completion6 Feb 2026
- Study completion6 Feb 2026
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.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908954
- Sponsor's protocol ID
- CLIN-60120-458
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Parallel-group Study to Evaluate the Single-dose Pharmacokinetics of Palovarotene in Male and Female Participants With Moderate and Severe Hepatic Impairment and Matched Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06908954
- Acronym / sponsor ID
- CLIN-60120-458
- Conditions
- Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 6 Feb 2026 (actual)
- Study completion
- 6 Feb 2026 (actual)
- First posted
- 3 Apr 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 main aim of this study is to understand how moderate and severe liver impairment (based on the Child-Pugh classification) affects the body's processing of a single dose of 10 mg maximum of palovarotene, compared to healthy participants with normal liver function.
The study will also assess the safety and tolerability of the single dose of palovarotene.
Participants will be enrolled in stages and divided into three groups based on their liver function:
- Group 1: Healthy participants with normal liver function
- Group 2: Participants with moderate liver impairment
- Group 3: Participants with severe liver impairment (only enrolled if Group 2 results are safe and acceptable)
Blood samples will be taken to assess how the drug binds to proteins in the blood. Participants will undergo various safety checks and procedures. Participants will stay in the clinical unit until Day 5 for these assessments and will return on Day 10 for a final visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 Healthy participants | Experimental | Drug: PalovaroteneEvaluation of the pharmacokinetics of IPN60120 in control healthy participants matching the age, sex and weight with hepatic impaired participants |
| Group 2 Moderate Hepatic impaired participants | Experimental | Drug: PalovaroteneEvaluation of the pharmacokinetics of IPN60120 in Moderate Hepatic impaired participants (Child-Pugh class B) |
| Group 3 Severe Hepatic impaired participants | Experimental | Drug: PalovaroteneEvaluation of the pharmacokinetics of IPN60120 in Severe Hepatic impaired participants (Child-Pugh class C) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female participants must be 18 to 70 years of age (inclusive) at the time of signing informed consent.
- Body weight at least 60.0 kg with body mass index (BMI) within the range of 18.0 and 36.0 kg/m² (inclusive), at screening. BMI of >36.0 to ≤40.0 may be eligible if participant has moderate ascites scoring 3 points on the C-P criteria.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials
- Clinical diagnosis of chronic hepatic disease (stable for more than 3 months) with a documented history of underlying hepatic insufficiency and no acute episodes of illness within 30 days prior to Day -1 (admission) and no significant change in disease status (i.e. up to 1 point in the C-P classification) from screening to Day -1.
- A stable medication regimen, defined as not starting new therapy(ies) or significant changing dosage(s) within 30 days prior to dosing.
Key exclusion criteria (14 listed)
- Presence or significant history of cardiovascular, respiratory, hepatic (except for the hepatic impairment for those concerned), renal, gastrointestinal, biliary, mucocutaneous, endocrinological, haematological or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Lymphoma, leukaemia or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years.
- Use of any medications (prescription or over the counter), herbal tea, energy drinks (including natural stimulants), herbal products (e.g. St. John's wort, garlic, milk thistle) or supplements/supratherapeutic doses of vitamins within 14 days prior to Day 1 and through discharge, apart from those approved by the investigator and the sponsor's medical monitor. Those with hepatic impairment may take concomitant medications
- Use of any medications that are moderate or strong inhibitors or inducers of CYP3A4
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 |
|---|---|---|
| PalovaroteneA single dose of maximum 10 mg of palovarotene will be administered orally on Day 1 to healthy control participants with normal hepatic function | Drug | Group 1 Healthy participants |
| PalovaroteneA single 10 mg dose of palovarotene will be administered orally on Day 1 to Moderate hepatic impaired participants (Child-Pugh class B) | Drug | Group 2 Moderate Hepatic impaired participants |
| PalovaroteneA single 10 mg dose of either 5 mg or 10 mg of palovarotene will be administered orally on Day 1 to Severe hepatic impaired participants (Child-Pugh class C). | Drug | Group 3 Severe Hepatic impaired participants |
Primary outcome
Maximum observed plasma drug concentration (Cmax)
Time frame: Over 96 hours postdose
Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 hours after dosing
Unbound fraction of drug in plasma (fu)
Time frame: Over 96 hours postdose
Measure of maximum observed plasma drug concentration (Cmax) (total and unbound) over 96 h after dosing
Time to maximum observed plasma concentration (Tmax)
Time frame: Over 96 hours postdose
Measure of AUC from time 0 to infinity (AUC0-∞) (total and unbound)
Area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUC0-∞)
Time frame: Over 96 hours postdose
Measure of AUC from time 0 to infinity (AUC0-∞) (total and unbound)
AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast)
Time frame: Over 96 hours postdose
Measure of AUC from 0 to time t corresponding to the last quantifiable concentration (AUC0-tlast) (total and unbound)
Apparent terminal elimination half life (T1/2)
Time frame: Over 96 hours postdose
Measure of apparent terminal elimination half-life over 96 hours post-dose
Apparent terminal elimination rate constant (λz).
Time frame: Over 96 hours postdose
Measure of apparent terminal elimination rate constant (λz) over 96 hours post-dose
5 secondary outcomes
Percentage of participants with Adverse Events (AEs)
Time frame: From Baseline to Day 10
Percentage of Participants with clinically significant changes from baseline in Laboratory Parameters
Time frame: At Day 2, Day 5 and Day 10
Percentage of participants with clinically significant change from baseline in physical examinations
Time frame: At Day 1, 2 and 3, Day 5 and Day 10
Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs
Time frame: At Day 1, 2 and 3, Day 5 and Day 10
Percentage of participants with clinically significant change from baseline in 12-lead Electrocardiogram (ECG) readings
Time frame: At Day 1, 2 and 3, Day 5 and Day 10
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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Ipsen Medical Director study director
Ipsen
4 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 Palovarotene in people with Hepatic Impairment and Healthy, run by Ipsen at 4 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 5 inclusion and 14 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 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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 drug concentration (Cmax) (time frame: Over 96 hours postdose). The study lists 7 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 30 Apr 2026.