Liver study tests new drug dosing
NCT ID NCT06336018
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at how the body processes a single dose of the drug etavopivat in people with mild, moderate, or severe liver disease compared to those with healthy livers. 48 adults took part. The goal was to understand how liver function affects drug levels and safety, which helps guide future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- etavopivat
- What this could lead to
- If successful, this study could help doctors determine the right dose of etavopivat for patients with liver problems.
- What could go wrong
- This is an early-phase study with only a single dose, so results may not predict long-term safety or effectiveness. Liver impairment can vary widely, making it hard to generalize.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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48 people
The number who actually took part.
- Started
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May 2024
- Finished
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Aug 2025
- Lead sponsor
-
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 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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 or female. * Age 18 years or above at the time of signing the informed consent. * Body mass index (BMI) between 18.5 and 42.0 kilogram per meter\^2 (kg/m\^2) (both inclusive) at screening. * Body weight greater than or equal to (\>=) 40.0 kilogram (kg) at screening. Specific inclusion criteria only for participants with hepatic impairment: * Participants with chronic (above 6 months), stable (no significant deterioration in hepatic function in last 2 months as determined by the investigator) hepatic impairment classified as Child-Pugh class A, B or C, as assessed by the investigator and which is confirmed and documented by medical history, physical examination and at least one of the following: hepatic ultrasound, computerised axial tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy. * Participants must be on a stable dose of medication and/or treatment regimen (e.g., no expectations of new medications nor changes to current medications within 14 days of dosing). Specific inclusion criterion only for participants with normal hepatic function: \- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and laboratory safety tests performed during screening visit, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods. * Participation (i.e., signed informed consent) in any interventional clinical study within 30 days or 5 times the half-life of the previous investigational medical product (IMP) (if known), whichever is longer, before screening. * Any disorder, unwillingness or inability, except for conditions associated with hepatic impairment in the group of participants with compromised hepatic function, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Participant is unable to refrain from or anticipates the use of, for 7 days prior to dosing and throughout the study, any drug known to be: * an inhibitor of uridine 5'-diphospho-glucuronosyltransferase (UGT) 2B7, * a strong inhibitor of cytochrome P450 (CYP)3A4 or CYP2C9, * a potent inhibitor of permeability glycoprotein (P-gp). * Participant is unable to refrain from or anticipates the use of, for 28 days prior to dosing and throughout the study, any drug known to be: * an inducer of UGT2B7, * a strong or moderate inducer of CYP3A4, including St. John's Wort, * a strong inducer of CYP2C9, * a potent inducer of P-gp. * Participant is unable to refrain from or anticipates the use of any medications or substances prohibited in the study. Specific exclusion criterion only for participants with hepatic impairment: \- Clinical signs of an acute hepatitis (viral as well as non-viral) or positive tests of hepatitis B virus surface antigen (HBsAg) (unless hepatitis B virus titre is negative) or antibody tests of hepatitis C virus (HCV-Ab) (unless negative polymerase chain reaction \[PCR\] for hepatitis C virus). Specific exclusion criteria only for participants with normal hepatic function: * Diagnostic test results positive for hepatitis B or hepatitis C infection. * History of diabetes mellitus or glycated haemoglobin (HbA1c) greater than or equal to 5 percent (48 millimoles per mole \[mmol/mol\]) at screening.
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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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Amer. Rrsch Corp-TX Liver Inst
San Antonio, Texas, 78215, United States
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Cure Clinical Research LLC
Orange, California, 92866, United States
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Orlando Clinical Research Center
Orlando, Florida, 32806, 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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