Status:
COMPLETED
A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants with moderate hepatic impairment (based on the Child-Pugh classification) to healthy participants. This is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04676425
Start Date
March 17 2021
End Date
January 25 2022
Last Update
October 6 2023
Active Locations (2)
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1
ProSciento Inc. ( Site 0002)
Chula Vista, California, United States, 91911
2
Clinical Pharmacology of Miami ( Site 0001)
Miami, Florida, United States, 33014