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Tiny study tests how liver disease changes drug processing

NCT ID NCT07049939

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Hepatic Insufficiency liver failure

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

  • University of Miami ( Site 0003)

    Miami, Florida, 33136, United States

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