ClinicalTrials.gg
RecruitingNCT07734610Updated Sep 23, 2026

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

A Phase 1 interventional study of Nemtabrutinib in Severe Renal Impairment and Healthy, sponsored by Merck Sharp & Dohme LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Renal Insufficiency by Merck Sharp & Dohme LLC — 2 open to participants now, 2 under way, none of them phase 3. Renal Insufficiency · Merck Sharp & Dohme LLC.

Planned enrollment
14th of 22
20 · median 24
Started
2026
with 2 others
Phase 1
22 of 22
2 open now
Registered
21st of 22
by date

Among the 22 studies in Renal Insufficiency by Merck Sharp & Dohme LLC, this one is the 14th largest by planned enrollment, is one of 3 that started in 2026, is one of 22 in phase 1, and was the 21st registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Phase 1this study22 · 2 open

By the year they started

First in 2003; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 24 across the 22 interventional studies. Of the 19 that completed or were terminated, 15 (79%) have results posted.

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02

Study 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.

03

Conditions studied

  • Severe Renal Impairment
  • Healthy

Browse trials for

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

All participants:

  • Has a (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 medical history

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Nemtabrutinib

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

    Drug: Nemtabrutinib

Interventions

06

What researchers measure

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.

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

Secondary outcomes

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

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

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

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

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

    Time frame: Up to approximately 24 hours postdose

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

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

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

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

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

    Time frame: Up to approximately 24 hours postdose

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

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

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

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

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

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

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

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

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

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

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

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

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

    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.

    Time frame: Up to approximately 15 days

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

    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.

    Time frame: Up to approximately 15 days

07

Study locations

1 of 1 sites recruiting
  • Floridian Clinical Research, LLC ( Site 0001)
    Miami Lakes, Florida 33016, United States
    Recruiting
    • Study Coordinator · Contact305-330-9977
08

References and documents

Individual participant data

Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Data sharing details ↗ · externaldatasharing-msd.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 4 months after the start.

Of 212 industry-sponsored phase 1 interventional studies under Renal Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 15. This study's planned 4 months is below that.

Counting every sponsor, half of 230 studies reached it within 8 months; a quarter within 5 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Jul 29, 2026
StartActual
Sep 8, 2026
Primary completionEst.
Feb 1, 2027
CompletionEst.
Feb 1, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07734610
Responsible party
Sponsor
First posted
Jul 29, 2026
Start date
Sep 8, 2026
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 23, 2026

Study contacts

Toll Free Number
Contact
Trialsites@msd.com
1-888-577-8839
Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: ARQ531

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