A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Doravirine (MK-1439) (MK-1439-019)

• Status: Completed
• Trial end date: 2014-05-12
• Target enrollment: 0
• Participant gender: All

Summary

This study aimed to investigate the influence of hepatic insufficiency on the pharmacokinetics (PK) of doravirine (MK-1439). In Part 1, PK of doravirine in participants with moderate hepatic insufficiency was compared with that of healthy control subjects matched with regard to mean age and weight. If a clinically meaningful increase in exposure of doravirine was observed in participants with moderate hepatic insufficiency in Part 1, study Part 2 was to evaluate PK of doravirine in participants with mild hepatic insufficiency.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) between 19 and 40 kg/m^2

• Continuous non-smoker or moderate smoker of <20 cigarettes or equivalent per day. Agrees to consume <=10 cigarettes or equivalent per day from the time of screening through the period of sample collection.

• In good health and with no clinically significant electrocardiogram abnormality

• Hepatic impairment participants: diagnosis of chronic (>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Part 1 only: score of 7 to 9 on the Child-Pugh scale. Part 2: score of 5 to 6 on the Child-Pugh scale.

• Females of childbearing potential: sexually inactive for >=14 days before study drug administration and throughout the study, or using 2 acceptable methods of barrier contraception from screening until 14 days after study drug administration.

Exclusion Criteria:

• Mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the study

• History or presence of clinically significant medical or psychiatric condition or disease

• History or presence of drug abuse within the past 2 years

• History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds

• Female participant who is pregnant or lactating

• Positive results for breath alcohol or urine drug screen (unless due to prescription drug use and is approved by the investigator) at screening

• Positive for HIV at screening

• Unable to refrain from or anticipates the use of any drug known to be a significant inhibitor or inducer of cytochrome oxidase CYP3A or P-glycoprotein, or any medication or substance which cannot be discontinued at least 14 days before study drug administration and throughout the study.

• Donation of >500 mL of blood or had significant blood loss within 56 days before study drug administration

• Plasma donation within 7 days before study drug administration

• Dosed in another clinical trial within 28 days before study drug administration

• Healthy control participants only: positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) at screening;