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

NCT06442436 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 1026-015MK-1026-015
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

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

Hepatic Impairment (HI)

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma

  The AUC0-inf of nemtabrutinib in plasma will be determined in each arm.

  Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose

• Maximum Concentration (Cmax) of Nemtabrutinib in Plasma

  The Cmax of nemtabrutinib in plasma will be determined in each arm.

  Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose

Secondary Outcomes (8)

• Area Under the Curve from Dosing to last (AUC0-last) of Nemtabrutinib in Plasma

  Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose

• Concentration 24 (C24) Hours Postdose of Nemtabrutinib in Plasma

  24 hours postdose

• Time to Maximum Concentration (Tmax) of Nemtabrutinib in Plasma

  Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose

• Apparent Terminal Half-life (t1/2) of Nemtabrutinib in Plasma

  Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose

• Apparent Total Clearance (CL/F) of Nemtabrutinib in Plasma

  Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose

Study Arms (2)

Panel A

EXPERIMENTAL

Participants with moderate hepatic impairment will receive a single oral dose of 25 mg nemtabrutinib on Day 1.

Drug: Nemtabrutinib

Panel B

EXPERIMENTAL

Healthy control participants will receive a single oral dose of 25 mg nemtabrutinib on Day 1.

Drug: Nemtabrutinib

Interventions

Nemtabrutinib DRUG

25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.

Also known as: MK-1026, ARQ 531

Panel A; Panel B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 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 AND/OR the participant has moderate impairment by the National Cancer Institution Organ Dysfunction Working Group (NCI-ODWG) classification system (moderate HI only).
• Is in general good health (except for Moderate HI).

You may not qualify if:

• Has a clinically significant condition that may affect absorption of the study drug in the opinion of the investigator, including gastric restrictions and bariatric surgery (eg, gastric bypass).
• Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history 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, latex allergy), 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 to receive 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 or equivalent/day).
• Is regular user of cannabis or any illicit drugs or has a history of drug (including alcohol) 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, or other 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 the results of the study or poses an additional risk to the participant by their participation in the study (moderate HI only).
• Has a history of recent variceal bleeds (for moderate HI only).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (3)

Clinical Pharmacology of Miami ( Site 0003)

Miami, Florida, 33172, United States

RECRUITING

Orlando Clinical Research Center ( Site 0001)

Orlando, Florida, 32809, United States

RECRUITING

Texas Liver Institute ( Site 0002)

San Antonio, Texas, 78215, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

ARQ531

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): September 14, 2026
• Study Completion (Estimated): September 14, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (3)