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

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: February 3, 2016
Last verified: January 2016

October 20, 2009
February 3, 2016
February 2010
November 2012   (final data collection date for primary outcome measure)
Number of Participants With Clinical and Laboratory Adverse Events (AEs) [ Time Frame: All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days) ] [ Designated as safety issue: Yes ]
An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
Number of Patients with Clinical and Laboratory Adverse Experiences [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00998985 on ClinicalTrials.gov Archive Site
  • Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7 [ Time Frame: Day 7 at the following time points: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose ] [ Designated as safety issue: No ]
    Blood samples were collected on Day 7 at pre-dose up to 24 hours post-dose in order to determine the AUC 0-24hrs of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir AUC0-24hr. exceeds 3.2 uM.hr.
  • 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 [ Time Frame: Day 7 at 24 hours post-dose ] [ Designated as safety issue: No ]
    Blood samples were collected on Day 7 at 24 hours post-dose in order to determine the C24hr of Grazoprevir. It is hypothesized that the Geometric Mean of Day 7 Grazoprevir C24hr exceeds 28 nM.
  • Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT1 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo [ Time Frame: Baseline and up to approximately 2 months ] [ Designated as safety issue: No ]
    Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA, expressed in international units (IU)/mL.
  • Maximum log10 HCV RNA Reduction From Baseline Following Administration of Grazoprevir in Participants With GT3 HCV or Pooled GT1 and GT3 HCV Participants Treated With Placebo [ Time Frame: Baseline and up to approximately 2 months ] [ Designated as safety issue: No ]
    Blood samples were collected at baseline and at intervals up to 2 months post-dose in order to determine the maximum log10 reduction from baseline in plasma HCV RNA.
  • 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 MK-5172 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)
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) 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. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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: 400 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 600 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 800 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 400 mg Grazoprevir - GT3
    GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 600 mg Grazoprevir - GT3
    GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 800 mg Grazoprevir - GT3
    GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 200 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 100 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 50 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 200 mg Grazoprevir - GT3
    GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 100 mg Grazoprevir - GT3
    GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 50 mg Grazoprevir - GT3
    GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 30 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
    Interventions:
    • Drug: Grazoprevir
    • Drug: Placebo
  • Experimental: 10 mg Grazoprevir - GT1
    GT1 HCV-infected Participants: 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:

  • Baseline health is stable.
  • Has a clinical diagnosis of chronic HCV infection.

Exclusion Criteria:

  • Has a history of stroke or chronic seizures.
  • 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.
Male
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Germany,   Russian Federation
 
NCT00998985
5172-004, 2009_678, 2009-015563-13
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2016

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