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A Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Moderate Hepatic Impairment
Led by Merck Sharp & Dohme LLC · Updated on 2026-02-11
32
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how nemtabrutinib, a drug given by mouth, behaves in the blood (pharmacokinetics) after a single dose in people with moderate liver impairment compared to healthy individuals. The study also aims to assess the safety and tolerability of nemtabrutinib in these participants. This is a Phase 1 clinical trial sponsored by Merck Sharp & Dohme LLC. Participants with moderate hepatic impairment and healthy matched controls each receive one oral dose of 25 mg nemtabrutinib on Day 1. The study groups include those with moderate liver impairment classified by specific medical criteria and healthy volunteers. Both groups receive the same dosage and form of the drug. Participants will have multiple blood samples taken before and at various times up to 336 hours after dosing to measure drug levels and related pharmacokinetic parameters. Safety is monitored through adverse event reports up to about 15 days. The total study duration includes dosing and follow-up assessments to evaluate how the drug is processed and tolerated in the body.
CONDITIONS
Brief 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.
- Is assigned male or female sex at birth. Participants assigned female sex at birth must not be pregnant or breast feeding and must be of nonchild bearing potential.
- Agrees to use contraception.
- Has provided documented informed consent for the study.
- Has a diagnosis of chronic (>6 months), stable hepatic impairment with features of cirrhosis due to any cause (moderate hepatic impairment only).
- Has moderate hepatic impairment (class B) by Child-Pugh or NCI-ODWG classification (moderate hepatic impairment only).
- Is in general good health except for moderate hepatic impairment.
You will not qualify if you...
- Has a condition affecting absorption of the study drug, including gastric restrictions or bariatric surgery.
- Is mentally or legally incapacitated or has a significant psychiatric disorder within last 5 years.
- Has a history of cancer.
- Has significant multiple or severe allergies or history of anaphylactic reaction to drugs or food.
- Had major surgery or donated/lost 1 unit of blood within 4 weeks before screening.
- Has received any vaccine within 14 days before or planned within 30 days after study intervention.
- Participated in another investigational study within 4 weeks prior to check-in.
- Is under age of consent.
- Is a heavy smoker (>20 cigarettes/day) or heavy nicotine user.
- Is a regular user of cannabis or illicit drugs or has recent history of drug/alcohol abuse.
- Consumes more than 3 alcoholic beverages per day.
- Consumes excessive caffeine (>6 servings per day).
- Is unwilling to comply with study restrictions.
- Has history or illness that could confound study results or increase risk (moderate hepatic impairment only).
- Has recent variceal bleeds, hepatorenal syndrome, fluctuating or worsening hepatic function (moderate hepatic impairment only).
- Has anticipated survival less than 3 months or MELD score ≥25 (moderate hepatic impairment only).
- Has history of liver or other organ transplant (moderate hepatic impairment only).
- Has active infection needing systemic therapy (moderate hepatic impairment only).
- Requires paracentesis more than twice monthly (moderate hepatic impairment only).
- Has transjugular intrahepatic portosystemic shunt or portacaval shunting (moderate hepatic impairment only).
- Has encephalopathy grade 3 or worse within 28 days before dosing (moderate hepatic impairment only).
- Received antiviral or immune therapy for hepatitis B or C within 90 days prior (moderate hepatic impairment only).
- Is positive for HIV-1 or HIV-2, HBV, or HCV (moderate hepatic impairment only).
- Taking unstable or non-withheld medications for chronic conditions (moderate hepatic impairment only).
- Has significant organ abnormalities or diseases (healthy controls only).
- Positive for hepatitis B surface antigen, hepatitis C antibodies, or HIV at screening (healthy controls only).
- Unable to refrain from medication use (healthy controls only).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to ~15 days
Participants receive a single oral dose of 25 mg nemtabrutinib. Pharmacokinetic blood samples are collected over approximately 14 days to assess drug levels and safety.
Multiple blood sampling visits over 14 days post-dose
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
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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