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Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
Sponsor: Merck Sharp & Dohme LLC
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
Conditions
Interventions
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