Status:
COMPLETED
Single-Dose Islatravir in Moderate Hepatic Impairment (MK-8591-030)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Human Immunodeficiency Virus (HIV) Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is an open-label, single-dose study of the plasma pharmacokinetics (PK), safety, and tolerability of islatravir (ISL, MK-8591), and the intracellular PK of ISL triphosphate (ISL-TP) in male and f...
Eligibility Criteria
Inclusion
- Healthy Control Participants:
- Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed prior to randomization
- Is in good health based on laboratory safety tests obtained at the screening visit and prior to administration of the initial dose of study drug.
- Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2
- Hepatic Impairment Participants:
- Has a diagnosis of chronic (\> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency with features of cirrhosis due to any etiology
- Has a score on the Child-Pugh scale ranging from 7 to 9 (moderate hepatic insufficiency) at screening
- With the exception of hepatic impairment, is in generally good health
- Has a BMI ≥ 18.5 and ≤ 40 kg/m2
- Healthy and Hepatic Impairment Participants:
- Males : uses contraception according to local regulations
- Females: is not pregnant or breastfeeding and one of the following applies:
- Is not a woman of childbearing potential (WOCBP) OR
- Is a WOCBP and uses an acceptable contraceptive method
- A WOCBP with negative highly sensitive pregnancy test within 24 hours of study intervention
Exclusion
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years
- Has a history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or non-prescription drugs or food
- Has known hypersensitivity to the active substance or any of the excipients of the study drug
- Is positive for hepatitis B surface antigen, hepatitis C antibodies, HIV-1 or HIV-2
- Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to study drug administration, throughout the study, until the poststudy visit
- Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit
- Has a QTc interval \>470 for males or \>480 ms for females, has a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), has uncorrected hypokalemia or hypomagnesemia, is taking concomitant medications that prolong the QT/QTc interval
- Is not considered low risk of having HIV infection
- Is a smoker or user of electronic cigarettes and/or has used nicotine or nicotine-containing products (eg, nicotine patch) within 3 months of screening
- Consumes greater than 3 glasses of alcoholic beverages per day
- Consumes more than 6 caffeinated beverages per day
- Is a regular user of illicit drugs or has a history of drug abuse within 2 years
- Presents any concern to the investigator regarding safe study participation
- Is unwilling to comply with study restrictions
- Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04515641
Start Date
November 5 2020
End Date
September 13 2021
Last Update
July 17 2025
Active Locations (1)
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1
Clinical Pharmacology of Miami ( Site 0001)
Miami, Florida, United States, 33014