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Small study checks how liver disease affects new drug processing

NCT ID NCT04676425

Knowledge-focused Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a single 4 mg dose of the drug elpipodect (MK-8189) in 14 people—some with mild or moderate liver problems and some healthy. Researchers measured how much drug stayed in the blood and for how long. The goal was to see if liver impairment changes drug levels, which could guide future dosing. No treatment benefit was tested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elpipodect (MK-8189)
What this could lead to
If successful, this study could help doctors decide the right dose of MK-8189 for patients with liver problems.
What could go wrong
This is a very early, small study with only 14 participants. It only looks at how the drug moves through the body, not whether it works for any disease.

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

14 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2022

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: * Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent) * Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention * (For hepatically impaired participants) Has a diagnosis of chronic (\>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment Exclusion Criteria: * Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases * Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies * Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food * Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) * Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit * Consumes greater than 3 glasses of alcoholic beverages per day * Consumes greater than 6 servings (1 serving is \~120 mg of caffeine) caffeinated beverages per day * (For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatic impairment

Contacts and locations

Locations

  • Clinical Pharmacology of Miami ( Site 0001)

    Miami, Florida, 33014, United States

  • ProSciento Inc. ( Site 0002)

    Chula Vista, California, 91911, United States

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