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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Vaniprevir 300 mg; Drug: Vaniprevir 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01010906

2009_674

7009-005

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 6 patient groups

Mild Hepatic Insufficiency (HI)

Experimental group

Description:

Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir

Treatment:

Drug: Vaniprevir 300 mg

Healthy Control to Mild HI

Experimental group

Description:

Healthy, matched to mild HI, control participants administered a single 300 mg oral tablet of vaniprevir

Treatment:

Drug: Vaniprevir 300 mg

Moderate HI

Experimental group

Description:

Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir

Treatment:

Drug: Vaniprevir 300 mg

Healthy Control to Moderate HI

Experimental group

Description:

Healthy, matched to moderate HI, control participants administered a single 300 mg oral tablet of vaniprevir

Treatment:

Drug: Vaniprevir 300 mg

Severe HI

Experimental group

Description:

Participants with severe HI administered a single 200 mg oral tablet of vaniprevir

Treatment:

Drug: Vaniprevir 200 mg

Healthy Control to Severe HI

Experimental group

Description:

Healthy, matched to severe HI, control participants administered a single 200 mg oral tablet of vaniprevir

Treatment:

Drug: Vaniprevir 200 mg