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Bruton's Tyrosine Kinase Inhibitor

Nemtabrutinib for Liver Disease

Phase 1
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 impairment with features of cirrhosis due to any etiology (moderate HI only).
Has moderate hepatic impairment (class B) by the Child-Pugh classification system (moderate HI only).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Awards & highlights

Summary

"This trial aims to see how the body processes a drug called nemabrutinib in people with liver problems compared to those with normal liver function. The study will also assess the safety and how well

Who is the study for?
This trial is for adults with a BMI of 18.0-40.0 who have chronic, stable moderate liver disease (Class B) and are not pregnant or breastfeeding. Participants must be in good general health, agree to use contraception, and provide informed consent.
What is being tested?
The study tests Nemtabrutinib's effects on participants with moderate liver impairment compared to healthy individuals by measuring drug levels in the blood after a single dose and assessing safety and tolerability.
What are the potential side effects?
While specific side effects are not listed here, the trial will monitor how well participants tolerate Nemtabrutinib and any adverse reactions they experience related to organ function or overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had stable liver disease with cirrhosis for over 6 months.
Select...
My liver function is moderately impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
Maximum Concentration (Cmax) of Nemtabrutinib in Plasma
Secondary outcome measures
Apparent Terminal Half-life (t1/2) of Nemtabrutinib in Plasma
Apparent Total Clearance (CL/F) of Nemtabrutinib in Plasma
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib in Plasma
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel BExperimental Treatment1 Intervention
Healthy control participants will receive a single oral dose of 25 mg nemtabrutinib on Day 1.
Group II: Panel AExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single oral dose of 25 mg nemtabrutinib on Day 1.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,967 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,079,764 Total Patients Enrolled
~11 spots leftby Feb 2025
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