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

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT04676425

Run by

Merck Sharp & Dohme LLC

People needed

14

Starts

2021-03-17

Expected to finish

2022-01-25

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• ProSciento Inc. ( Site 0002) — Chula Vista, California, United States
• Clinical Pharmacology of Miami ( Site 0001) — Miami, Florida, United States

Full record on ClinicalTrials.gov

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