Tiny study tests how liver disease changes drug processing
NCT ID NCT07049939
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how the drug bomedemstat behaves in people with mild or moderate liver impairment compared to healthy volunteers. Nine participants received a single dose, and researchers measured drug levels in the blood. The goal is to understand if liver problems require dose adjustments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bomedemstat (MK-3543)
- What this could lead to
- If successful, this study could help doctors decide the right dose of bomedemstat for people with liver problems.
- What could go wrong
- This is a very early, small study with only 9 participants, so results may not apply to everyone. The drug may still cause side effects.
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
-
9 people
The number who actually took part.
- Started
-
Aug 2025
- Finished
-
Feb 2026
- 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 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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 The main inclusion criteria include but are not limited to the following: * Is a non-smoker or is a moderate smoker for at least 3 months prior to dosing Participants with Mild and Moderate HI * Is classified as having either mild HI (Group 1) or moderate HI (Group 2) score on the Child-Pugh scale ranging from 5 to 6 (mild) or 7 to 9 (moderate) * Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology Healthy Control Participants: * Must match the mean age (± 15 years) of participants with mild HI and moderate HI * Must match the mean body-mass index (BMI) (± 25%) of participants with mild HI (Group 1) and moderate HI * Must match the sex ratio (±2) of participants in each HI group, separately Exclusion Criteria The main exclusion criteria include but are not limited to the following: All Participants * History of cancer (malignancy) * Female participants of childbearing potential * Is positive for Hepatitis C virus (HCV) * Is positive for Hepatitis B surface antigen (HBsAg) * Is positive for human immunodeficiency virus (HIV) Participants with Mild and Moderate HI * Has any significant arrhythmia or conduction abnormality * Severe complications of liver disease within the preceding 3 months * Primary biliary cholangitis or biliary obstruction * Has a history of a recent variceal bleeds * Has evidence of hepatorenal syndrome * Has a history of liver or other solid organ transplantation * Has an active infection requiring systemic therapy * Requires paracentesis more often than 2 times per month * Has transjugular intrahepatic portosystemic shunt and/or has undergone portacaval shunting Healthy Control Participants * Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases * Is a regular user of cannabis products within approximately 6 months of 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
-
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, 32809, United States
-
The Texas Liver Institute ( Site 0002)
San Antonio, Texas, 78215, United States
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University of Miami ( Site 0003)
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New cholesterol drug tested in liver patients
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