A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)

Completed · Phase 1

Conditions studied: Renal Impairment

In brief

The goal of this study is to evaluate the effect of moderate and severe renal impairment (RI) on the pharmacokinetics (PK), safety, and tolerability of MK-8527. There will be no hypothesis testing in the study.

Key facts

Study ID

NCT06295796

Run by

Merck Sharp & Dohme LLC

People needed

18

Starts

2024-06-20

Expected to finish

2025-01-31

Last updated by the study team

2026-02-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The main inclusion criteria include but are not limited to the following:
• Moderate and Severe RI
• With the exception of RI, is in sufficient health for study participation.
• Has stable renal function.
• Healthy
• Matches mean age to participants with moderate and severe RI.
• Has normal renal function.

You may not qualify if…

• The main exclusion criteria include but are not limited to the following:
• All participants
• History of cancer (malignancy).
• Positive test results for Human-immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV).
• Had a major surgery or lost significant volume of blood within 56 days prior to dosing.
• Donated plasma within 7 days prior to dosing.
• Moderate and Severe RI
• Failed renal transplant or had a nephrectomy.
• End stage renal disease requiring dialysis.
• Any significant arrhythmia or conduction abnormality.
• Has non-sustained or sustained ventricular tachycardia.

Where it is running

• Research by Design ( Site 0001) — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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