A Study of Enlicitide Chloride (MK-0616 Oral PCSK9 Inhibitor) in Participants With Moderate Renal Impairment (MK-0616-007)

NCT ID: NCT05070390

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-16
• Study Completion Date: 2023-05-03

Brief Summary

This study evaluated the safety, tolerability and pharmacokinetic (PK) effects of enlicitide chloride in participants with moderate renal impairment (RI) to those of healthy matched control participants. Moderate RI was defined as the estimated glomerular filtration rate (eGFR) ≥30 and <60milliliter/minute/1.73meters^2 (ml/min/1.73m^2). There is no formal hypothesis.

Conditions

Moderate Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panel A - Moderate Renal Impairment (RI)

Single dose of enlicitide chloride 10 mg

Group Type: EXPERIMENTAL

Enlicitide Chloride

Intervention Type: DRUG

10 mg capsule administered orally

Panel B - Healthy Controls

Single dose of enlicitide chloride 10 mg

Group Type: EXPERIMENTAL

Enlicitide Chloride

Intervention Type: DRUG

10 mg capsule administered orally

Interventions

Enlicitide Chloride

10 mg capsule administered orally

Intervention Type: DRUG

Other Intervention Names

MK-0616

Eligibility Criteria

Inclusion Criteria

• Good health based upon medical history, physical examination, vital signs, laboratory safety tests, and electrocardiograms (ECG) performed before randomization
• Body mass index (BMI) ≥18 kg/m^2 and ≤40 kg/m^2
• Male participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: Refrain from donating sperm, PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent, or use acceptable contraception per study protocol
• Female participants must be of non-childbearing potential
• Moderate RI participants: Baseline estimated glomerular filtration rate (eGFR) ≥30 and <60 mL/min/1.73 m^2 based on the Modification of Diet in Renal Disease (MDRD) equation
• Moderate Renal Impairment (RI) participants: No clinically significant change in renal status at least 1 month prior to dosing and not currently receiving or has not previously been on hemodialysis
• Healthy Matched Controls: eGFR ≥80 mL/min/1.73 m^2 based on the MDRD equation

Exclusion Criteria

• Healthy Matched Controls: history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator
• History of cancer, with the exception of adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study
• History of significant multiple and/or severe allergies
• Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV)
• History of major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
• Moderate RI participants: Does not agree to follow the smoking restrictions as defined by the study
• Healthy Matched Controls: History of smoking and/or has used nicotine or nicotine-containing products (eg, nicotine patch and electronic cigarette) within 3 months of screening
• Received any nonlive vaccine starting from 14 days prior to study intervention or is scheduled to receive any nonlive vaccine through 30 days following study intervention with the exception of Corona virus disease (COVID-19) vaccine administration. Study intervention must be given at least 72 hours following or at least 48 hours prior to any COVID-19 vaccination
• Consumes greater than 3 servings of alcoholic beverages per day
• Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day
• Regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Velocity Clinical Research, Hallandale Beach ( Site 0002)

Hallandale, Florida, United States

Alliance for Multispecialty Research, LLC ( Site 0001)

Knoxville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

MK-0616-007

Identifier Type: OTHER

Identifier Source: secondary_id

0616-007

Identifier Type: -

Identifier Source: org_study_id