A Study to Investigate the Influence of Hepatic Impairment on Elpipodect (MK-8189) Treatment (MK-8189-012)

NCT04676425 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 8189-012MK-8189-012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the pharmacokinetics (PK) of elpipodect in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is Part 1 of the study; following review of the safety and PK data from Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done, Part 2 of the study will compare the PK of elpipodect in participants with mild hepatic impairment to healthy participants.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MK-8189

  AUC0-inf is a measure of the total amount of drug in the plasma from the dose administration extrapolated to infinity. Blood samples collected pre and post-dose at multiple timepoints were used to estimate AUC0-inf following MK-8189 administration. Geometric least-squares mean and confidence intervals for AUC0-inf were calculated using a linear fixed effects model performed on natural log-transformed values.

  Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy participants); 60, 84, 108 and 120 hours post-dose (hepatic impairment participants)

• Maximum Observed Plasma Concentration (Cmax) of MK-8189

  Cmax is the maximum concentration of MK-8189 observed in plasma. Blood samples collected pre and post-dose at multiple timepoints were used to estimate Cmax following MK-8189 administration. Geometric least-squares mean and confidence intervals of Cmax were calculated using a linear fixed effects model performed on natural log-transformed values.

  Pre-dose (0), 2, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 hours post-dose (hepatic impairment and healthy); 60, 84, 108 and 120 hours post-dose (hepatic impairment)

Secondary Outcomes (2)

• Number of Participants Who Experience One or More Adverse Events (AEs)

  Up to approximately 15 days

• Number of Participants Who Discontinue From the Study Due to an AE

  Up to approximately 15 days

Study Arms (2)

Moderate Hepatic Impairment Participants

EXPERIMENTAL

Participants with hepatic impairment will receive a single dose of elpipodect 4 mg orally on Day 1.

Drug: Elpipodect

Healthy Participants

EXPERIMENTAL

Healthy participants will receive a single dose of MK-8189 4 mg orally on Day 1.

Drug: Elpipodect

Interventions

Elpipodect DRUG

Administered at a dose of 4 mg via oral tablet

Also known as: MK-8189

Healthy Participants; Moderate Hepatic Impairment Participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
• Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
• (For hepatically impaired participants) Has a diagnosis of chronic (\>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment

You may not qualify if:

• Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
• Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
• Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
• Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
• Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
• Consumes greater than 3 glasses of alcoholic beverages per day
• Consumes greater than 6 servings (1 serving is \~120 mg of caffeine) caffeinated beverages per day
• (For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (2)

ProSciento Inc. ( Site 0002)

Chula Vista, California, 91911, United States

Location

Clinical Pharmacology of Miami ( Site 0001)

Miami, Florida, 33014, United States

Location

MeSH Terms

Interventions

MK-8189

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: March 17, 2021
• Primary Completion: January 16, 2022
• Study Completion: January 25, 2022
• Last Updated: April 29, 2026
• Results First Posted: October 6, 2023

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)