A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK-7009-005)

• Status: Completed
• Trial end date: 2010-06-21
• Target enrollment: 0
• Participant gender: All

Summary

This was a 3-part study comparing the pharmacokinetics after administration of vaniprevir (MK-7009) for participants with mild, moderate or severe hepatic insufficiency with healthy matched control participants. The primary hypothesis is that the area under the curve (AUC) (0 to infinity) of vaniprevir for participants with mild, moderate, or severe hepatic insufficiency is similar to that observed in healthy matched controlled participants.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

Hepatic Participants:

• Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study

• Apart from hepatic insufficiency, is in good general health

• Has a diagnosis of chronic stable hepatic insufficiency

• Score on the Child-Pugh scale ranged from 5 to 6 (mild hepatic insufficiency); from 7 to 9 (moderate hepatic insufficiency); from 10 to 15 (severe hepatic insufficiency). Moderate and Severe participants must have had a 50% score of 2 or higher on at least one of the laboratory parameters (i.e., albumin, prothrombin time, bilirubin) at the prestudy visit.

Healthy Matched Participants:

• Females of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study

• Is in good health

Exclusion Criteria:

• Female is pregnant, lactating, expecting to become pregnant or donate eggs

• Has a history of stroke or seizures

• Has a history of cancer

• Is unable to refrain from the use of any prescription or non-prescription medication

• Consumes excessive amounts of alcohol or caffeinated beverages daily

• Has had surgery, donated blood or participated in another investigational study with in the last 4 weeks

• Is a regular user or past abuser of any illicit drug including alcohol