Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
