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A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK7009)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01010906
First received: November 6, 2009
Last updated: June 23, 2010
Last verified: June 2010
History of Changes

November 6, 2009
June 23, 2010
July 2009
June 2010   (final data collection date for primary outcome measure)
AUC(0-infinity) of vaniprevir following single dose administration [ Time Frame: 48 hours postdose ] [ Designated as safety issue: No ]
AUC(0-infinity) of MK7009 following single dose administration [ Time Frame: 48 hours postdose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01010906 on ClinicalTrials.gov Archive Site
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A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of Vaniprevir (MK7009)
An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009

A 3-part study comparing the pharmacokinetics after administration of vaniprevir to patients with mild, moderate or severe hepatic insufficiency with healthy matched control subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009
  • Experimental: 1
    Part 1 - Mild Hepatic Patients
    Intervention: Drug: vaniprevir (MK7009)
  • Experimental: 2
    Part 1 - Healthy Subjects
    Intervention: Drug: vaniprevir (MK7009)
  • Experimental: 3
    Part 2 - Moderate Hepatic Patients
    Intervention: Drug: vaniprevir (MK7009)
  • Experimental: 4
    Part 2 - Healthy Subjects
    Intervention: Drug: vaniprevir (MK7009)
  • Experimental: 5
    Part 3 - Severe Hepatic Patients
    Intervention: Drug: vaniprevir (MK7009)
  • Experimental: 6
    Part 3 - Healthy Subjects
    Intervention: Drug: vaniprevir (MK7009)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Hepatic Patients:

  • Female patients of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
  • Apart from hepatic insufficiency patient is in good general health
  • Patient has a diagnosis of chronic stable hepatic insufficiency

Healthy Matched Subjects:

  • Female subjects of reproductive potential test negative for pregnancy and agree to use an appropriate method of contraception during the study
  • Subject is in good health

Exclusion Criteria:

  • Female patient is pregnant, lactating, expecting to become pregnant or donate eggs
  • Patient has a history of stroke or seizures
  • Patient has a history of cancer
  • Patient is unable to refrain from the use of any prescription or non-prescription medication
  • Patient consumes excessive amounts of alcohol or caffeinated beverages daily
  • Patient has had surgery, donated blood or participated in another investigational study with in the last 4 weeks
  • Patient is a regular user or past abuser of any illicit drug including alcohol
Both
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01010906
2009_674, MK7009-005
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP