Study the Safety and Effectiveness of MK7009 in Hepatitis C Infected Patients (MK-7009-004)(COMPLETED)
NCT ID: NCT00518622
Last Updated: 2015-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2007-07-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
25 mg b.i.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
2
75 mg b.i.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
3
250 mg b.i.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
4
500 mg b.i.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
5
700 mg b.i.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
6
125 mg q.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
7
600 mg q.d. MK7009
Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
8
Placebo
Comparator: Placebo
MK7009 Placebo
Interventions
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Comparator: MK7009
Depending on group assignment, patients will receive once daily (q.d.) dosing for 8 days or twice daily (b.i.d.) dosing for 7 days plus one additional dose on Day 8.
Comparator: Placebo
MK7009 Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has chronic Hepatitis C
* Subject is willing to not use alcohol for 2 weeks prior to therapy and through the study follow-up period
Exclusion Criteria
* Patient has human immunodeficiency virus (HIV)
* Patient has Hepatitis B
18 Years
55 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Lawitz E, Sulkowski M, Jacobson I, Kraft WK, Maliakkal B, Al-Ibrahim M, Gordon SC, Kwo P, Rockstroh JK, Panorchan P, Miller M, Caro L, Barnard R, Hwang PM, Gress J, Quirk E, Mobashery N. Characterization of vaniprevir, a hepatitis C virus NS3/4A protease inhibitor, in patients with HCV genotype 1 infection: safety, antiviral activity, resistance, and pharmacokinetics. Antiviral Res. 2013 Sep;99(3):214-20. doi: 10.1016/j.antiviral.2013.05.015. Epub 2013 Jun 7.
Other Identifiers
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2007_517
Identifier Type: -
Identifier Source: secondary_id
7009-004
Identifier Type: -
Identifier Source: org_study_id
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