CompletedPhase 1

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

United States14 participantsStarted 2021-03-17

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

What they're measuring

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

Timeframe: 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

Timeframe: 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)

Trial details

NCT IDNCT04676425

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-01-16

Results submitted2022-12-05

View on ClinicalTrials.gov More Hepatic Impairment trials