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

NCT ID: NCT01010906

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-01
• Study Completion Date: 2010-06-21

Brief 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.

Conditions

Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild Hepatic Insufficiency (HI)

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

Group Type: EXPERIMENTAL

Vaniprevir 300 mg

Intervention Type: DRUG

single dose administration of 300 mg oral tablet

Healthy Control to Mild HI

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

Group Type: EXPERIMENTAL

Vaniprevir 300 mg

Intervention Type: DRUG

single dose administration of 300 mg oral tablet

Moderate HI

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

Group Type: EXPERIMENTAL

Vaniprevir 300 mg

Intervention Type: DRUG

single dose administration of 300 mg oral tablet

Healthy Control to Moderate HI

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

Group Type: EXPERIMENTAL

Vaniprevir 300 mg

Intervention Type: DRUG

single dose administration of 300 mg oral tablet

Severe HI

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

Group Type: EXPERIMENTAL

Vaniprevir 200 mg

Intervention Type: DRUG

single dose administration of 200 mg oral tablet

Healthy Control to Severe HI

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

Group Type: EXPERIMENTAL

Vaniprevir 200 mg

Intervention Type: DRUG

single dose administration of 200 mg oral tablet

Interventions

Vaniprevir 300 mg

single dose administration of 300 mg oral tablet

Intervention Type: DRUG

Vaniprevir 200 mg

single dose administration of 200 mg oral tablet

Intervention Type: DRUG

Other Intervention Names

MK-7009; MK-7009

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2009_674

Identifier Type: -

Identifier Source: secondary_id

7009-005

Identifier Type: -

Identifier Source: org_study_id