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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010906
• Other study ID #: 7009-005
• Secondary ID: 2009_674
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2009
• Est. completion date: June 21, 2010

Study information

• Verified date: September 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 21, 2010
• Est. primary completion date: June 11, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Hepatitis C

Intervention

Drug:
• Vaniprevir 300 mg
single dose administration of 300 mg oral tablet
• Vaniprevir 200 mg
single dose administration of 200 mg oral tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-48 hours postdose
Secondary	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.	0-48 hours postdose