Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004 AM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00998985
First received: October 20, 2009
Last updated: November 6, 2014
Last verified: November 2014

October 20, 2009
November 6, 2014
February 2010
November 2012   (final data collection date for primary outcome measure)
Number of Patients with Clinical and Laboratory Adverse Experiences [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00998985 on ClinicalTrials.gov Archive Site
  • Area under the curve (AUC[0-24hr]) of Grazoprevir on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • 24 hour plasma concentration (C[24]) of Grazoprevir on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • HCV viral load following administration of Grazoprevir compared to placebo [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • AUC(0-24hr) of MK5172 on day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • C (24hr) of MK5172 on Day 7 of dosing [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • HCV viral load following administration of MK5172 compared to placebo [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004 AM3)
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK5172 in Hepatitis C Infected Male Patients

This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of Grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hepatitis C
  • Drug: Grazoprevir
    10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
  • Drug: Placebo
    Placebo tablet, orally, once a day for 7 days
  • Experimental: Panel A
    GT1 HCV-infected Patients: 400 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel B
    GT1 HCV-infected Patients: 600 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel C
    GT1 HCV-infected Patients: 800 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel D
    GT3 HCV-infected Patients: 400 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel E
    GT3 HCV-infected Patients: 600 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel F
    GT3 HCV-infected Patients: 800 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel G
    GT1 HCV-infected Patients: 200 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel H
    GT1 HCV-infected Patients: 100 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel I
    GT1 HCV-infected Patients: 50 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel J
    GT3 HCV-infected Patients: 200 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel K
    GT3 HCV-infected Patients: 100 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel L
    GT3 HCV-infected Patients: 50 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel M
    GT1 HCV-infected Patients: 30 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: Panel N
    GT1 HCV-infected Patients: 10 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
November 2012
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients baseline health is stable.
  • Patient has a clinical diagnosis of chronic HCV infection.

Exclusion Criteria:

  • Patient has a history of stroke or chronic seizures.
  • Patient has a history of cancer.
  • Patient has a history of HIV infection.
  • Patient has had major surgery, donated blood or participated in another investigational study within the past 3 months.
Male
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00998985
5172-004, 2009_678
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP