NCT06295796

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

Name: Clinical Trial NCT06295796
Creator: Merck Sharp & Dohme LLC
Keywords: Renal Impairment, MK-8527, Phase 1, drug, clinical trial

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

Merck Sharp & Dohme LLC·Phase 1·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Renal Impairment
Drug/Device/Intervention: MK-8527
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Merck Sharp & Dohme LLC

Timeline & enrollment

Phase: Phase 1
Start date: Jun 24, 2024
End date: Apr 21, 2025
Enrollment: 18 participants

Primary outcome

Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of MK-8527 in plasma,Area under the concentration versus time curve from time 0 to infinity (AUC0-inf) of MK-8527 in plasma,Maximum concentration (Cmax) of MK-8527 in plasma,Time to Maximum concentration (Tmax) of MK-8527 in plasma,Apparent terminal half-life (t1/2) of MK-8527 in plasma,Apparent Clearance (CL/F) of MK-8527 in plasma,Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma

Summary

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.

ICD-10 classifications

Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06295796
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06295796 through Pure Global AI's free database. This Phase 1 trial is sponsored by Merck Sharp & Dohme LLC and is currently Not yet recruiting. The study focuses on Renal Impairment. Target enrollment is 18 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.