Severe Renal ImpairmentPhase 1NCT07734610
A Clinical Trial of Nemtabrutinib in Participants With Severe Kidney Disease (MK-1026-027)
A Phase 1 study testing Nemtabrutinib in people with Severe Renal Impairment and Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Renal Impairment, Healthy
- 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2026to 1 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Floridian Clinical Research, LLC ( Site 0001)
Miami Lakes, Florida, 33016
Study Coordinator, 305-330-9977
About this study
Official title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Severe Renal Impairment
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
- Severe Renal Impairment, Healthy
- Being tested
- Nemtabrutinib
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemtabrutinibDrug
Also called MK-1026
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Nemtabrutinib | Experimental | All participants will receive a single oral dose of 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 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.
Measured: 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
Blood samples will be collected to determine the AUC0-last of Nemtabrutinib in plasma.
Measured: 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
Blood samples will be collected to determine the AUC0-24 of Nemtabrutinib.
Measured: Up to approximately 24 hours postdose
Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the (Cmax) of Nemtabrutinib.
Measured: At designated timepoints up to approximately 336 hours postdose
Concentration at 24 Hours Postdose (C24) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the C24 of Nemtabrutinib.
Measured: Up to approximately 24 hours postdose
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the (Tmax) of Nemtabrutinib.
Measured: At designated timepoints up to approximately 336 hours postdose
Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma
Blood samples will be collected to determine the (t1/2) of Nemtabrutinib.
Measured: At designated timepoints up to approximately 336 hours postdose
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Blood samples will be collected to determine the CL/F of Nemtabrutinib.
Measured: At designated timepoints up to approximately 336 hours postdose
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.
Measured: At designated timepoints up to approximately 336 hours postdose
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.
Measured: Up to approximately 15 days
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.
Measured: Up to approximately 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start8 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Renal ImpairmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734610
- Sponsor's protocol ID
- 1026-027
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Nemtabrutinib in Participants With Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT07734610
- Acronym / sponsor ID
- 1026-027
- Conditions
- Severe Renal Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nemtabrutinib | Experimental | Drug: NemtabrutinibAll participants will receive a single oral dose of nemtabrutinib on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a body mass index (BMI) ≥18.0 and ≤40.0 kg/m^2
- The participant has stable renal function as determined by historical measurements.
- Is medically healthy with no clinically significant medical history
Key exclusion criteria (5 listed)
- 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.
- 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
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-1026Oral administration | Drug | Nemtabrutinib |
Primary outcome
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.
10 secondary outcomes
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
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
Maximum Plasma Concentration (Cmax) of Nemtabrutinib in Plasma
Time frame: At designated timepoints up to approximately 336 hours postdose
Concentration at 24 Hours Postdose (C24) of Nemtabrutinib in Plasma
Time frame: Up to approximately 24 hours postdose
Time of the Maximum Observed Concentration (Tmax) of Nemtabrutinib in Plasma
Time frame: At designated timepoints up to approximately 336 hours postdose
Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma
Time frame: At designated timepoints up to approximately 336 hours postdose
Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib
Time frame: At designated timepoints up to approximately 336 hours postdose
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
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 15 days
Number of Participants Who Discontinue From the Study Due to an AE
Time frame: Up to approximately 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
1 site 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 Severe Renal Impairment and Healthy, run by Merck Sharp & Dohme LLC at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 23 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.