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.

CT.gov Identifier
NCT07734610
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Merck & Co./Merck Sharp & Dohme (MSD)
Collaborator
N/A
Study Contact Information
+1 908 740 4000
Recruiting
Contact Us

Study Details

Diseases
Focal Segmental Glomerulosclerosis
Study Drug
Nemtabrutinib
See More
MK-1026
Genes
N/A
Study Dates
Sep 2026 - Feb 2027
Sex
Female & Male
Age
18 - 80 Years
Inclusion and Exclusion 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

Protocol 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 Locations

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