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A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008) - Trial NCT06295796

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.

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NCT06295796
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06295796
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A Study of MK-8527 in Participants With Moderate and Severe Renal Impairment (MK-8527-008)
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MK-8527 in Participants With Moderate and Severe Renal Impairment

Study Focus

Renal Impairment

MK-8527

Interventional

drug

Sponsor & Location

Merck Sharp & Dohme LLC

Timeline & Enrollment

Phase 1

Jun 24, 2024

Apr 21, 2025

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT06295796

Non-Device Trial