Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07734610

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Floridian Clinical Research, LLC ( Site 0001)

Miami Lakes, Florida, 33016, United States

Location status: Recruiting

Location contact

Study Coordinator

CONTACT

305-330-9977

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

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

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

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

Treatment and study plan

Nemtabrutinib

Drug

Oral administration

Other names: MK-1026

Primary outcomes

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

    Time frame: At designated timepoints up to approximately 336 hours postdose

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

Secondary outcomes

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

    Time frame: At designated timepoints up to approximately 336 hours postdose

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

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

    Time frame: Up to approximately 24 hours postdose

    Blood samples will be collected to determine the AUC0-24 of Nemtabrutinib.

  3. Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma

    Time frame: At designated timepoints up to approximately 336 hours postdose

    Blood samples will be collected to determine the (Cmax) of Nemtabrutinib.

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

    Time frame: Up to approximately 24 hours postdose

    Blood samples will be collected to determine the C24 of Nemtabrutinib.

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

    Time frame: At designated timepoints up to approximately 336 hours postdose

    Blood samples will be collected to determine the (Tmax) of Nemtabrutinib.

  6. Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma

    Time frame: At designated timepoints up to approximately 336 hours postdose

    Blood samples will be collected to determine the (t1/2) of Nemtabrutinib.

  7. Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib

    Time frame: At designated timepoints up to approximately 336 hours postdose

    Blood samples will be collected to determine the CL/F of Nemtabrutinib.

  8. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Nemtabrutinib in Plasma

    Time frame: At designated timepoints up to approximately 336 hours postdose

    Blood samples will be collected to determine the Vz/F of Nemtabrutinib.

  9. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 15 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

  10. Number of Participants Who Discontinue From the Study Due to an AE

    Time frame: Up to approximately 15 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue from the study due to an AE will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Severe Renal Impairment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.