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

CompletedPhase 1

Sponsor: Merck Sharp & Dohme LLC

Conditions: Hepatic Impairment

Interventions: Elpipodect

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (2)

Chula Vista, California, United States
Miami, Florida, United States