A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009
Tracking Information
Start Date ICMJE | July 2009 |
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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 |
Descriptive Information
Brief Title ICMJE | A Study Investigating the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK7009 |
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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 |
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Recruitment Information
Estimated Enrollment ICMJE | 60 | ||||
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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:
Healthy Matched Subjects:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 45 Years to 65 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT01010906 | ||||
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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 |
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Information Provided By | Merck |
Source: http://clinicaltrials.gov/