Actively Recruiting
A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)
Led by Merck Sharp & Dohme LLC · Updated on 2026-02-11
32
Participants Needed
3
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemtabrutinib (MK-1026) following a single oral dose of nemtabrutinib in participants with moderate hepatic impairment to that of healthy matched control participants and to evaluate the safety and tolerability of nemtabrutinib.
CONDITIONS
Official Title
A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive.
- Assigned male or female sex at birth; females must not be pregnant or breastfeeding and must be of nonchild bearing potential.
- Agrees to use contraception.
- Has provided documented informed consent.
- Diagnosed with chronic (>6 months), stable moderate hepatic impairment (cirrhosis) with no acute illness episodes within 2 months.
- Has moderate hepatic impairment (class B) by Child-Pugh classification or moderate impairment by NCI-ODWG system.
- Is in general good health aside from moderate hepatic impairment.
You will not qualify if you...
- Has conditions that may affect drug absorption, including gastric restrictions or bariatric surgery.
- Mentally or legally incapacitated, with significant emotional problems or psychiatric disorders in the last 5 years.
- History of cancer (malignancy).
- History of severe allergies or anaphylactic reactions to drugs or food.
- Major surgery or blood donation/loss within 4 weeks prior to the study.
- Received any vaccine within 14 days before or scheduled during 30 days after study intervention.
- Participated in another investigational study within 4 weeks or 5 half-lives prior to check-in.
- Under age 18.
- Heavy smoker or heavy nicotine user (>20 cigarettes or equivalent/day).
- Regular cannabis or illicit drug use, or history of drug or alcohol abuse within 3 months.
- Consumes more than 3 alcoholic drinks daily.
- Consumes excessive caffeine (more than 6 servings of coffee, tea, cola, energy drinks, or similar daily).
- Unwilling to comply with study restrictions.
- Has illness or history that may confound results or increase risk.
- Recent variceal bleeding.
- Evidence of hepatorenal syndrome.
- Rapidly worsening hepatic function.
- Anticipated survival less than 3 months with MELD score ≥25.
- History of liver or other organ transplant.
- Active infection requiring systemic therapy.
- Requires frequent paracentesis (more than twice per month).
- Has certain shunts (transjugular intrahepatic portosystemic or portacaval).
- Encephalopathy Grade 3 or worse within 28 days before dosing.
- Received antiviral or immune therapy for hepatitis B or C within 90 days.
- Positive for HIV-1 or HIV-2 or using HIV protease inhibitors.
- Positive for hepatitis B or C.
- On unstable medication regimen or unable to stop medications for study period.
- For healthy controls: history of significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or neurological diseases.
- For healthy controls: positive tests for hepatitis B surface antigen, hepatitis C antibodies, or HIV.
- For healthy controls: unable to refrain from medication use during study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, United States, 33172
Actively Recruiting
2
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, United States, 32809
Actively Recruiting
3
Texas Liver Institute ( Site 0002)
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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