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

Start Date ^ICMJE	July 2009
Estimated Primary Completion Date	December 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 ^ICMJE	Same as current
Change History	No Changes Posted

Brief Title ^ICMJE	A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009
Official Title ^ICMJE	An 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 Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Condition ^ICMJE	Hepatitis C
Intervention ^ICMJE	Drug: 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

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

December 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

Gender

Both

Ages

45 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

Russian Federation

NCT ID ^ICMJE

NCT01010906

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2009_674, MK7009-005

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck