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An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Moderate and Severe Renal Impairment


Description

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.

Trial Eligibility

Inclusion Criteria: 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. Exclusion Criteria: 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.

Study Info

Organization

Merck Sharp & Dohme LLC


Primary Outcome

Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma


Outcome Timeframe Predose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours post dose

NCTID NCT06295796

Phases PHASE1

Primary Purpose TREATMENT

Start Date 2024-06-20

Completion Date 2025-04-21

Enrollment Target 18

Interventions

DRUG MK-8527

Locations Recruiting

Research by Design ( Site 0001)

United States, Illinois, Chicago


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