Hepatic Impairment (HI)Phase 1NCT06442436

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

A Phase 1 study testing Nemtabrutinib in people with Hepatic Impairment (HI), run by Merck Sharp & Dohme LLC at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment (HI)
What is being tested?: Nemtabrutinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 3 sitesUnited States
Study dates: 24 Jul 2024to 13 Aug 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 31Show fewer

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).
Has evidence of hepatorenal syndrome (for moderate HI only).
Has fluctuating or rapidly deteriorating hepatic function within the prestudy period, in the opinion of the investigator (for moderate HI only).
Is not in sufficient health, with regard to stability of HI, to undergo participation in the study with anticipated survival of <3 months, in keeping with a Model 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 portacaval shunting (for moderate HI only).
Has encephalopathy Grade 3 or worse within 28 days before administration of study intervention (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 HI only).
Is positive for human immunodeficiency virus (HIV)-1 or HIV-2 or using HIV protease inhibitors (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 a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(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 or acquired coagulation or platelet disorder), hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke, intracranial hemorrhage, and chronic seizures) abnormalities or diseases (for healthy control participants only).
Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or HIV at the prestudy (screening) visit (for healthy control participants only).
Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies (for healthy control participants only).

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Clinical Pharmacology of Miami ( Site 0003)
Miami, Florida, 33172
Orlando Clinical Research Center ( Site 0001)
Orlando, Florida, 32809
Texas Liver Institute ( Site 0002)
San Antonio, Texas, 78215

Other trials in United States

About this study

Official title: A Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Moderate Hepatic Impairment

Conditions: Hepatic Impairment (HI)
Being tested: Nemtabrutinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NemtabrutinibDrug
Also called MK-1026, ARQ 531
25 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.

Study groups in NCT06442436
Study group	Role	What they receive
Panel A	Experimental	Participants with moderate hepatic impairment will receive a single oral dose of 25 mg nemtabrutinib on Day 1. Receives: Drug: Nemtabrutinib
Panel B	Experimental	Healthy control participants will receive a single oral dose of 25 mg nemtabrutinib on Day 1. Receives: Drug: Nemtabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
The AUC0-last of nemtabrutinib in plasma will be determined in each arm.
Measured: 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
The C24 of nemtabrutinib in plasma will be determined in each arm.
Measured: 24 hours postdose
Time to Maximum Concentration (Tmax) of Nemtabrutinib in Plasma
The Tmax of nemtabrutinib in plasma will be determined in each arm.
Measured: 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
The t½ of nemtabrutinib in plasma will be determined in each arm.
Measured: 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
The CL/F of nemtabrutinib in plasma will be determined in each arm.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib in Plasma
The Vz/F of nemtabrutinib in plasma will be determined in each arm.
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Number of Participants who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants experiencing AEs will be reported.
Measured: Up to ~15 days
Number of Participants Who Discontinue From the Study Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants discontinuing study treatment due to an AE will be reported.
Measured: Up to ~15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jul 202413 Aug 2026

First posted4 Jun 2024
Study start24 Jul 2024
Primary completion13 Aug 2026
Study completion13 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic Impairment (HI)Studies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06442436
Sponsor's protocol ID: 1026-015
Other IDs: MK-1026-015
Status last verified: Aug 2026
First submitted: 29 May 2024
Last updated: 2 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
Healthy Adult Participants, Hepatic Impairment (HI)
RecruitingPhase 1
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Advanced Malignancies and Hepatic Impairment
RecruitingPhase 1
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
Hepatic Impairment (HI)
RecruitingPhase 1
Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Impaired Hepatic Function
RecruitingPhase 1
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Hepatic Impairment, Moderate Hepatic Impairment

All Hepatic Impairment (HI) trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Moderate Hepatic Impairment
ClinicalTrials.gov ID: NCT06442436
Acronym / sponsor ID: 1026-015
Conditions: Hepatic Impairment (HI)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Jul 2024 (actual)
Primary completion: 13 Aug 2026 (actual)
Study completion: 13 Aug 2026 (actual)
First posted: 4 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Panel A	Experimental	Drug: NemtabrutinibParticipants with moderate hepatic impairment will receive a single oral dose of 25 mg nemtabrutinib on Day 1.
Panel B	Experimental	Drug: NemtabrutinibHealthy control participants will receive a single oral dose of 25 mg nemtabrutinib on Day 1.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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).

Key exclusion criteria (31 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NemtabrutinibAlso: MK-1026, ARQ 53125 mg nemtabrutinib (1 x 5 mg and 1 x 20 mg tablets) administered orally as a single dose.	Drug	Panel A, Panel B

Primary outcome

Area Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
The AUC0-inf of nemtabrutinib in plasma will be determined in each arm.
Maximum Concentration (Cmax) of Nemtabrutinib in Plasma
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
The Cmax of nemtabrutinib in plasma will be determined in each arm.

8 secondary outcomes

Area Under the Curve from Dosing to last (AUC0-last) of Nemtabrutinib in Plasma
Time frame: 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
Time frame: 24 hours postdose
Time to Maximum Concentration (Tmax) of Nemtabrutinib in Plasma
Time frame: 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
Time frame: 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
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib in Plasma
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose
Number of Participants who Experience One or More Adverse Events (AEs)
Time frame: Up to ~15 days
Number of Participants Who Discontinue From the Study Due to an Adverse Event (AE)
Time frame: Up to ~15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Merck Clinical Trials InformationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatic Impairment (HI)

RecruitingPhase 1
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
Healthy Adult Participants, Hepatic Impairment (HI)
RecruitingPhase 1
Pharmacokinetics and Safety Study of Pelabresib in Patients With Advanced Malignancies and Hepatic Impairment
Advanced Malignancies and Hepatic Impairment
RecruitingPhase 1
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
Hepatic Impairment (HI)
RecruitingPhase 1
Pharmacokinetics of Petrelintide in Participants With Impaired Hepatic Function
Impaired Hepatic Function
RecruitingPhase 1
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)
Hepatic Impairment, Moderate Hepatic Impairment

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nemtabrutinib in people with Hepatic Impairment (HI), run by Merck Sharp & Dohme LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve from Dosing to Infinity (AUC0-inf) of Nemtabrutinib in Plasma (time frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 192, 240, and 336 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06442436.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.