A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
NCT ID: NCT00998985
Last Updated: 2018-07-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
91 participants
INTERVENTIONAL
2010-02-23
2012-11-08
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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400 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
600 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
800 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
400 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
600 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
800 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
200 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
100 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
50 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
200 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
100 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
50 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
30 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
10 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
Interventions
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Grazoprevir
10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
Placebo
Placebo tablet, orally, once a day for 7 days
Eligibility Criteria
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Inclusion Criteria
* Has a clinical diagnosis of chronic HCV infection.
Exclusion Criteria
* Has a history of cancer.
* Has a history of human immunodeficiency virus (HIV) infection.
* Has had major surgery, donated blood or participated in another investigational study within the past 3 months.
18 Years
65 Years
MALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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Yeh WW, Fraser IP, Jumes P, Petry A, Lepeleire I, Robberechts M, Reitmann C, Van Dyck K, Huang X, Guo Z, Panebianco D, Nachbar RB, O'Mara E, Wagner JA, Butterton JR, Dutko FJ, Moiseev V, Kobalava Z, Huser A, Visan S, Schwabe C, Gane E, Popa S, Ghicavii N, Uhle M, Wagner F. Antiviral Activity, Safety, and Tolerability of Multiple Ascending Doses of Elbasvir or Grazoprevir in Participants Infected With Hepatitis C Virus Genotype-1 or -3. Clin Ther. 2018 May;40(5):704-718.e6. doi: 10.1016/j.clinthera.2018.03.002. Epub 2018 Apr 25.
Study Documents
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Document Type: CSR Synopsis
View DocumentOther Identifiers
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2009_678
Identifier Type: OTHER
Identifier Source: secondary_id
2009-015563-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
5172-004
Identifier Type: -
Identifier Source: org_study_id
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