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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Hepatic Insufficiency
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014