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NCT05934292
PHASE1

Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The primary objective of the study is to compare the plasma pharmacokinetics (PK) of enlicitide decanoate following a single 20 mg dose in participants on a background of statin therapy with varying degrees of renal impairment (moderate, severe, end stage renal disease \[ESRD\]) to those of healthy mean matched control participants on a background of statin therapy. There is no formal hypothesis.

Official title: An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of MK-0616 in Participants With Varying Degrees of Renal Impairment

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2023-07-20

Completion Date

2024-01-19

Last Updated

2026-09-30

Healthy Volunteers

Yes

Interventions

DRUG

Enlicitide Decanoate

Oral dose

Locations (5)

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, United States

Clinical Pharmacology of Miami ( Site 0005)

Miami, Florida, United States

Advanced Pharma CR, LLC ( Site 0001)

Miami, Florida, United States

Orlando Clinical Research Center ( Site 0004)

Orlando, Florida, United States

Genesis Clinical Research, LLC ( Site 0002)

Tampa, Florida, United States