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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01010906
First received: November 6, 2009
Last updated: June 23, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: vaniprevir (MK7009)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • AUC(0-infinity) of vaniprevir following single dose administration [ Time Frame: 48 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Part 1 - Mild Hepatic Patients
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009
Experimental: 2
Part 1 - Healthy Subjects
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009
Experimental: 3
Part 2 - Moderate Hepatic Patients
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009
Experimental: 4
Part 2 - Healthy Subjects
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009
Experimental: 5
Part 3 - Severe Hepatic Patients
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009
Experimental: 6
Part 3 - Healthy Subjects
Drug: vaniprevir (MK7009)
single dose administration of 300 mg oral tablet
Other Name: MK7009

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010906

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01010906     History of Changes
Other Study ID Numbers: 2009_674, MK7009-005
Study First Received: November 6, 2009
Last Updated: June 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 15, 2014