Liver function and drug processing: a new study
NCT ID NCT05481411
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the drug olpasiran is processed by the body in people with mild, moderate, or severe liver problems compared to those with healthy livers. A total of 25 adults took a single dose of the drug. The goal was to understand safety and how the liver affects drug levels, not to treat a disease.
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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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25 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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May 2023
- 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
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18 to 75 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 or female participants of nonchildbearing potential, between 18 and 75 years of age (inclusive) at the time of Screening. * Body mass index between 18.0 and 40.0 kg/m\^2 (inclusive) at the time of Screening. Participants with Normal Hepatic Function Only: • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee). Participants with Hepatic Impairment Only: • Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings. Exclusion Criteria: * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). * Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2 (Groups 1-3) or \< 50 mL/min/1.73m\^2 (Group 4 only) by Modification of Diet in Renal Disease formula at Screening or Check-in. * Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer) before receiving olpasiran. * Participants who were previously exposed to olpasiran. * Female participants with a positive pregnancy test at Screening or Check-in. Participants with Normal Hepatic Function Only: * Positive hepatitis panel. Participants whose results are compatible with prior immunization may be included. * Alanine aminotransferase and aspartate aminotransferase elevations \> 3x upper limit of normal at Screening or Check-in. Participants with Hepatic Impairment Only: * Positive for hepatitis B surface antigen. Participants with positive hepatitis B core antibody may be included if hepatitis B surface antigen is negative. Participants with positive hepatitis B surface antibody may be included (consistent with prior vaccination). * Active malignancy of any type. Participants with a history of malignancy that has been eradicated with supporting medical documentation indicating that there is no residual malignancy detected in the past 2 years will be allowed. * Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).
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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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Inland Empire Clinical Trials, LLC
Rialto, California, 92377, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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The Texas Liver Institute, Inc.
San Antonio, Texas, 78215, United States
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Other studies related to the condition(s) this trial covers.
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