Phase 1 N=60 Treatment

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

Hepatitis C

Bottom Line

View on ClinicalTrials.gov: NCT01010906 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration — 2.68; 1.48; 5.09; 1.64 µM.hr

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Vaniprevir 300 mg (Drug); Vaniprevir 200 mg (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve (AUC) (0-infinity) of Vaniprevir in Blood Plasma Following Single Dose Administration	2.68; 1.48; 5.09; 1.64; 7.79; 0.925	—
SECONDARY Maximum Concentration (Cmax) of Vaniprevir in Blood Plasma Following Single Dose Administration	0.922; 0.586; 1.88; 0.852; 2.06; 0.335	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01010906). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.