A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027)

NCT07734610 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 1026-027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to learn what happens to nemtabrutinib in a person's body when given to participants with severe kidney disease and to healthy participants.

Conditions

Healthy; Severe Renal Impairment

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma

  Blood samples will be collected to determine the AUC0-inf of Nemtabrutinib in plasma.

  At designated timepoints up to approximately 336 hours postdose

Secondary Outcomes (10)

• Area Under the Concentration Versus Time Curve from 0 to the Time of the Last Quantifiable Sample (AUC0-last) of Nemtabrutinib

  At designated timepoints up to approximately 336 hours postdose

• Area Under the Concentration Versus Time Curve from 0 to 24 Hours Postdose (AUC0-24) of Nemtabrutinib

  Up to approximately 24 hours postdose

• Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma

  At designated timepoints up to approximately 336 hours postdose

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

  Up to approximately 24 hours postdose

• Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma

  At designated timepoints up to approximately 336 hours postdose

Study Arms (1)

Nemtabrutinib

EXPERIMENTAL

All participants will receive a single oral dose of nemtabrutinib on Day 1.

Drug: Nemtabrutinib

Interventions

Nemtabrutinib DRUG

Oral administration

Also known as: MK-1026

Nemtabrutinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants:
• Has a body mass index (BMI) ≥18.0 and ≤40.0 kg/m\^2
• Participants with Severe Renal impairment (RI):
• The participant has stable renal function as determined by historical measurements.
• Healthy volunteers:
• Is medically healthy with no clinically significant medical history

You may not qualify if:

• Renal Impairment Participants:
• History of any illness, other than renal impairment, 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.
• Healthy Matched Control Participants:
• History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Floridian Clinical Research, LLC ( Site 0001)

Miami Lakes, Florida, 33016, United States

RECRUITING

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 29, 2026
• Study Start: September 8, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)