A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009


Tracking Information

Start Date  ICMJEJuly 2009
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 6, 2009)
AUC(0-infinity) of MK7009 following single dose administration [ Time Frame: 48 hours postdose ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryNo Changes Posted

Descriptive Information

Brief Title  ICMJEA Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009
Official Title  ICMJEAn Open-label, 3-Part, Single-Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009
Brief Summary

A 3-part study comparing the pharmacokinetics after administration of MK7009 to patients with mild, moderate or severe hepatic insufficiency with healthy matched control subjects.

Detailed Description 
Study PhasePhase I
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Condition  ICMJEHepatitis C
Intervention  ICMJEDrug: MK7009
single dose administration of 300mg oral tablet
Study Arms / Comparison Groups
  • 1: Experimental
    Part 1 - Mild Hepatic Patients
    Intervention: Drug: MK7009
  • 2: Experimental
    Part 1 - Healthy Subjects
    Intervention: Drug: MK7009
  • 3: Experimental
    Part 2 - Moderate Hepatic Patients
    Intervention: Drug: MK7009
  • 4: Experimental
    Part 2 - Healthy Subjects
    Intervention: Drug: MK7009
  • 5: Experimental
    Part 3 - Severe Hepatic Patients
    Intervention: Drug: MK7009
  • 6: Experimental
    Part 3 - Healthy Subjects
    Intervention: Drug: MK7009

Recruitment Information

Estimated Enrollment  ICMJE60
Estimated Completion DateMarch 2010
Estimated Primary Completion DateDecember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 pat abuser of any illicit drug including alcohol
GenderBoth
Ages45 Years to 65 Years
Accepts Healthy VolunteersYes
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJERussian Federation

Administrative Information

NCT ID  ICMJENCT01010906
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2009_674, MK7009-005
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck