Liver study tests how palovarotene behaves in impaired patients
NCT ID NCT06908954
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how moderate and severe liver impairment changes the way the body handles a single dose of palovarotene, compared to healthy people. Thirty-one participants were split into three groups based on liver function and received up to 10 mg of the drug. Researchers measured drug levels in the blood and checked for side effects to understand dosing needs for liver-impaired patients.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- palovarotene
- What this could lead to
- If successful, this study could help doctors determine the right dose of palovarotene for people with liver problems, making the drug safer to use.
- What could go wrong
- This is a very early, small study (31 people) focused on drug processing, not on treating a disease. Results may not apply to real-world use or predict long-term safety.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
31 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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American Research Corporation/Texas Liver Institute
San Antonio, Texas, 78215, United States
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ERG - Clinical Pharmacology of Miami
Miami, Florida, 33172, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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Pinnacle Clinical Research
San Antonio, Texas, 78229, United States
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