A Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439 (MK-1439-019)
Status: | Completed |
---|---|
Conditions: | HIV / AIDS, Gastrointestinal |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 5/5/2014 |
Start Date: | March 2014 |
End Date: | October 2014 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
A 2-Part, Open-Label, Singe-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-1439
This study will investigate the influence of hepatic insufficiency on the pharmacokinetics
(PK) of MK-1439. In Part 1, PK of MK-1439 in participants with moderate hepatic
insufficiency will be compared with that of healthy control subjects matched with regard to
mean age and weight. If a clinically meaningful increase in MK-1439 exposure is observed in
participants with moderate hepatic insufficiency in Part 1, study Part 2 will evaluate PK of
MK-1439 in participants with mild hepatic insufficiency.
(PK) of MK-1439. In Part 1, PK of MK-1439 in participants with moderate hepatic
insufficiency will be compared with that of healthy control subjects matched with regard to
mean age and weight. If a clinically meaningful increase in MK-1439 exposure is observed in
participants with moderate hepatic insufficiency in Part 1, study Part 2 will evaluate PK of
MK-1439 in participants with mild hepatic insufficiency.
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;
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