A Clinical Study of Enlicitide Decanoate in People With Liver Function Problems (MK-0616-030)

Merck Sharp & Dohme LLC20 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 or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health. This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Insufficiency Hepatic Impairment

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: All participants: * Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study * Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2 Participants with moderate or mild HI: * Diagnosis of chronic (\> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause. * Is generally in good health with the exception of HI. Healthy Control Participants: * Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles Exclusion Criteria: The main exclusion criteria include but are not limited to the following: All participants: * History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery. * History of cancer * Consumes greater than 3 servings of alcoholic beverages per day. * Is on statin background therapy. Participants with moderate or mild HI: * Severe complications of liver disease within 3 months of entering the study.

Locations (2)

Orlando Clinical Research Center ( Site 0002)

Orlando, Florida, United States

The Texas Liver Institute ( Site 0001)

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide

AUC0-inf of enlicitide in plasma will be determined.

Time frame: Pre-dose and at designated time points up to 168 hours post dose

Part 1: Maximum concentration (Cmax) of enlicitide

Cmax of enlicitide in plasma will be determined

Time frame: Predose, and at designated timepoints up to 168 hours post-dose

Part 2: AUC 0-inf of enlicitide

AUC 0-inf of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2: Cmax of enlicitide

Cmax of enlicitide in plasma will be determined

Time frame: Predose, and at designated timepoints up to 168 hours post-dose

Secondary Outcomes

Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide

AUC0-24 of enlicitide in plasma will be determined.

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide

AUC0-last of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide

Tmax of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 1: Apparent terminal half-life (t1/2) of enlicitide

t1/2 of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 1: Apparent clearance (CL/F) of enlicitide

CL/F of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide

Vz/F of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 1: Number of participants who experience one or more adverse events (AEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately 6 weeks

Part 1: Number of participants who discontinue study intervention due to an AE

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately 6 weeks

Part 2: AUC0-24 of enlicitide

AUC0-24 of enlicitide in plasma will be determined.

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2: AUC0-last of enlicitide

AUC0-last of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2: Tmax observed plasma drug concentration of enlicitide

Tmax of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2: t1/2 of enlicitide

t1/2 of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2: CL/F of enlicitide

CL/F of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2: Vz/F of enlicitide

Vz/F of enlicitide in plasma will be determined

Time frame: Pre-dose and at designated timepoints up to 168 hours post dose

Part 2 Number of participants who experience one or more adverse events (AEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately 6 weeks

Part 2: Number of participants who discontinue study intervention due to an AE

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately 6 weeks

Data from ClinicalTrials.gov

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