Liver Function's impact on drug levels under study
NCT ID NCT06952634
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the body processes a drug called ESK001 in people with different levels of liver function. Researchers gave a single dose to 32 adults, including healthy volunteers and those with mild, moderate, or severe liver impairment. The goal was to measure drug levels in the blood and check for side effects. This helps doctors understand if dose adjustments are needed for patients with liver problems.
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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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32 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Mar 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
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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.
Key Inclusion Criteria for All Participants: * Body mass index between 18.0 and 40.0 kg/m2 Key Inclusion Criteria for Participants with Hepatic Impairment: * Diagnosis of chronic (\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history Key Exclusion Criteria for All Participants: * Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure \< 90 mmHg and/or diastolic blood pressure \< 50 mmHg), or resting pulse rate \< 45 or \> 100 bpm. Measurements may be repeated once in order to determine eligibility Key Exclusion Criteria for Healthy Volunteer: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee. * Positive hepatitis panel and/or positive human immunodeficiency virus test. Key Exclusion Criteria for Participants with Hepatic Impairment: * History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening. * History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study. * Liver function tests outside the appropriate reference ranges that are not consistent with hepatic dysfunction, as determined by the investigator or designee. * QTcF \> 480 ms for males or \> 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats.
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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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Alliance for Multispecialty Research
Knoxville, Tennessee, 37920, United States
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Orange County Research Center
Lake Forest, California, 92630, United States
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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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Panax Clinical Research
Miami Lakes, Florida, 33104, United States
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Other studies related to the condition(s) this trial covers.
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