A Study of Nemtabrutinib in Participants With Moderate Hepatic Impairment (MK-1026-015)

Last updated: March 6, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

Nemtabrutinib

Clinical Study ID

NCT06442436
1026-015
MK-1026-015
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to compare the plasma pharmacokinetics (PK) of nemabrutinib (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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 birthmust not be pregnant or breast feeding and must be of nonchild bearing potential.

  • Who agrees to use contraception.

  • Has provided documented informed consent for the study.

  • Has a diagnosis of chronic (>6 months), stable (no acute episodes of illness withinthe previous 2 months due to deterioration in hepatic function) hepatic impairmentwith 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).

  • Is in general good health (except for Moderate HI).

Exclusion

Exclusion Criteria:

  • Has a clinically significant condition that may affect absorption of the study drugin the opinion of the investigator, including gastric restrictions and bariatricsurgery (eg, gastric bypass).

  • Is mentally or legally incapacitated, has significant emotional problems at the timeof prestudy (screening) visit or expected during the conduct of the study or has ahistory of clinically significant psychiatric disorder of the last 5 years.

  • Has a history of cancer (malignancy).

  • Has a history of significant multiple and/or severe allergies (eg, food, drug, latexallergy), or has had an anaphylactic reaction or significant intolerability (systemic allergic reaction) to prescription or nonprescription drugs or food.

  • Had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL)within 4 weeks prior to the prestudy.

  • Has received any vaccine starting from 14 days prior to study or is scheduled toreceive any vaccine through 30 days following study intervention.

  • Was dosed in another investigational study within 4 weeks (or 5 half-lives,whichever is greater) prior to check-in (Day -1).

  • Is under the age of consent.

  • Is heavy smoker or heavy user of nicotine-containing products (>20 cigarettes orequivalent/day).

  • Is regular user of cannabis or any illicit drugs or has a history of drug (includingalcohol) abuse within approximately 3 months.

  • Consumes greater than 3 servings of alcoholic beverages per day.

  • Consumes excessive amounts, defined as greater than 6 servings of coffee, tea, cola, (1 serving is approximately equivalent to 120 mg of caffeine) energy drinks, orother caffeinated beverages per day.

  • Is unwilling to comply with the study restrictions.

  • Has a history or illness that in the opinion of the investigator, might confound theresults of the study or poses an additional risk to the participant by theirparticipation in the study (moderate HI only).

  • Has a history of recent variceal bleeds (for moderate HI only).

  • Has evidence of hepatorenal syndrome (for moderate HI only).

  • Has fluctuating or rapidly deteriorating hepatic function within the prestudyperiod, in the opinion of the investigator (for moderate HI only).

  • Is not in sufficient health, with regard to stability of HI, to undergoparticipation in the study with anticipated survival of <3 months, in keeping with aModel for End-Stage Liver Disease (MELD) score of ≥25 (for moderate HI only).

  • Has a history of liver or other solid organ transplantation (for moderate HI only).

  • Has an active infection requiring systemic therapy (for moderate HI only).

  • Who requires paracentesis more often than 2 times per month (for moderate HI only).

  • Has a transjugular intrahepatic portosystemic shunt and/or has undergone portacavalshunting (for moderate HI only).

  • Has encephalopathy Grade 3 or worse within 28 days before administration of studyintervention (for moderate HI only).

  • Has received antiviral and/or immune modulating therapy for hepatitis B virus (HBV)or hepatitis C virus (HCV) within 90 days prior to study start (for moderate HIonly).

  • Is positive for human immunodeficiency virus (HIV)-1 or HIV-2 or using HIV proteaseinhibitors (for moderate HI only).

  • Is positive for HBV (for moderate HI only).

  • Is positive for HCV (for moderate HI only).

  • Is taking medications to treat chronic medical conditions and has not been on astable regimen for at least 1 month and/or is unable to withhold the use of themedication(s) for the prohibited period of time in study (for moderate HI only).

  • Has a history of clinically significant endocrine, gastrointestinal, cardiovascular,hematological (history of a bleeding disorder, abnormal bleeding or a hereditary oracquired coagulation or platelet disorder), hepatic, immunological, renal,respiratory, genitourinary, or major neurological (including stroke, intracranialhemorrhage, and chronic seizures) abnormalities or diseases (for healthy controlparticipants only).

  • Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis Cantibodies, or HIV at the prestudy (screening) visit (for healthy controlparticipants only).

  • Is unable to refrain from or anticipates the use of any medication, includingprescription and nonprescription drugs or herbal remedies (for healthy controlparticipants only).

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: Nemtabrutinib
Phase: 1
Study Start date:
July 24, 2024
Estimated Completion Date:
August 08, 2025

Connect with a study center

  • Clinical Pharmacology of Miami ( Site 0003)

    Miami, Florida 33172
    United States

    Active - Recruiting

  • Orlando Clinical Research Center ( Site 0001)

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Texas Liver Institute ( Site 0002)

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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