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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaniprevir 300 mg

Drug

single dose administration of 300 mg oral tablet

Other names: MK-7009

Vaniprevir 200 mg

Drug

single dose administration of 200 mg oral tablet

Other names: MK-7009

Primary outcomes

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

Time frame: 0-48 hours postdose

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.

Secondary outcomes

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

Time frame: 0-48 hours postdose

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK-7009

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Nov 10, 2009
Registry last updated: Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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