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Clinical Trials/NCT07734610
NCT07734610RecruitingPhase 1

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

Merck Sharp & Dohme LLC1 site in 1 country20 target enrollmentStarted: September 17, 2026Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Area Under the Concentration Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Nemtabrutinib in Plasma
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Nemtabrutinib

Experimental

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

Intervention: Nemtabrutinib (Drug)

Outcomes

Primary Outcomes

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

  • Area Under the Concentration Versus Time Curve from 0 to 24 Hours Postdose (AUC0-24) of Nemtabrutinib(Up to approximately 24 hours postdose)
  • 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)
  • 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)
  • Time of the Maximum Observed Concentration (t1/2) of Nemtabrutinib in Plasma(At designated timepoints up to approximately 336 hours postdose)
  • Apparent Total Plasma Clearance (CL/F) of Nemtabrutinib(At designated timepoints up to approximately 336 hours postdose)
  • Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Nemtabrutinib in Plasma(At designated timepoints up to approximately 336 hours postdose)
  • Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 15 days)
  • Number of Participants Who Discontinue From the Study Due to an AE(Up to approximately 15 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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