A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)

Merck Sharp & Dohme LLC27 enrolled

Overview

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward, The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Renal Impairment

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Body Mass Index (BMI) between 18 and 40 kg/m\^2, inclusive * On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * History or presence of renal artery stenosis * Had a functioning renal transplant in the past 5 years and is taking transplant medication * History of gastrointestinal (GI) disease which might affect food and drug absorption Panel A: Participants with Severe Renal Impairment: \- History of any illness, other than hypercholesterolemia and Renal Impairment Panel B: Healthy Participants: \- History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia

Locations (5)

Velocity Clinical Research, New Smyrna Beach ( Site 0003)

Edgewater, Florida, United States

Velocity Clinical Research, Hallandale Beach ( Site 0006)

Hallandale, Florida, United States

Nature Coast Clinical Research - Inverness ( Site 0002)

Inverness, Florida, United States

Jacksonville Center for Clinical Research ( Site 0004)

Jacksonville, Florida, United States

Genesis Clinical Research, LLC ( Site 0001)

Tampa, Florida, United States

Outcomes

Primary Outcomes

Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma

AUC0-24 of enlicitide in plasma will be determined.