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Not yet recruiting NCT07734610

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

Phase I Interventional Severe Renal Impairment Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nemtabrutinib.
Who it may be relevant to
Registry conditions: Severe Renal Impairment, Healthy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Nemtabrutinib
    Oral administration

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07734610 · 1026-027

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗