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

Merck Sharp & Dohme LLC60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

Vaniprevir 300 mgDRUG

single dose administration of 300 mg oral tablet

Vaniprevir 200 mgDRUG

single dose administration of 200 mg oral tablet

Eligibility

Sex: ALLMin age: 45 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration

Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The AUC (0-infinity) of vaniprevir in blood plasma was based on an analysis of covariance (ANCOVA) model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.

Time frame: 0-48 hours postdose

Secondary Outcomes

Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration

Participants were administered a single dose of vaniprevir; then their blood was collected at the following time points: 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, 24, 32 and 48 hours postdose. The Cmax of vaniprevir in blood plasma was based on an ANCOVA model used to analyze natural log-transformed values that were back-transformed to derive geometric least-squares mean and confidence interval.

Time frame: 0-48 hours postdose

Data from ClinicalTrials.gov

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