Liver function and drug safety: new study on varegacestat
NCT ID NCT06841315
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how the drug varegacestat moves through the body in people with liver problems compared to healthy people. About 35 adults took a single dose, and researchers measured drug levels and side effects. The goal was to understand if liver impairment changes how the drug works, which helps guide future dosing.
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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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35 people
The number who actually took part.
- Started
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Mar 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 84 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (Healthy Participants): * Healthy, adult, male or female (of nonchildbearing potential only), 18 to 84 years of age, inclusive, at the screening visit. Participant will be matched by age (± 10 years) and sex to a participant with hepatic impairment (HI). Each healthy participant may be matched to more than 1 participant with HI, but cannot be matched to more than 1 participant within the same HI group. * Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs as deemed by the PI or designee Inclusion Criteria (Hepatic Impairment): * Healthy, apart from HI, adult male or female (of nonchildbearing potential only), 18 to 84 years of age, inclusive, at the screening visit. * Considered to have HI (of any etiology) that has been clinically stable (no acute episodes of illness due to deterioration in hepatic function) for at least 1 month prior to dosing per the PI and Sponsor and is likely to remain stable throughout the study. To be classified as having hepatic impairment with known medical history of liver disease (with or without a known history of alcohol abuse). * Has a score on the Child-Pugh scale at screening visit and confirmed at check-in as follows: Mild: ≥5 and ≤6 \[Category A\]; or Moderate: ≥7 and ≤9 \[Category B\]; or Severe: ≥10 and ≤15 \[Category C\]. \- Medically healthy, apart from HI, with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs as deemed by the PI or designee Exclusion Criteria (Healthy Volunteers): * Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study. Exclusion Criteria (Hepatic Impairment): Participants must not be enrolled in the study, if they meet any of the following criteria: * Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * History or presence of clinically significant medical (except for HI) or psychiatric condition or disease in the opinion of the PI or designee. * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or pose an additional risk to the participant by their participation in the study.
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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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Orlando Clinical Research Center
Orlando, Florida, 32809, United States
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The Texas Liver Institute
San Antonio, Texas, 78215, United States
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Other studies related to the condition(s) this trial covers.
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