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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00998985
Recruitment Status : Completed
First Posted : October 21, 2009
Results First Posted : March 2, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Grazoprevir Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
Actual Study Start Date : February 23, 2010
Actual Primary Completion Date : November 8, 2012
Actual Study Completion Date : November 8, 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 400 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
 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: 600 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
 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: 800 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
 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 - GT3
GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
 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: 600 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
 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: 800 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
 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: 200 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
 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: 100 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
 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: 50 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
 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: 200 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
 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: 100 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
 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: 50 mg Grazoprevir - GT3
GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
 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: 30 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
 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: 10 mg Grazoprevir - GT1
GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7 [ Time Frame: Day 7 at 24 hours post-dose ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00998985


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme Corp.
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:

Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00998985    
Other Study ID Numbers: 5172-004
2009_678 ( Other Identifier: Merck )
2009-015563-13 ( EudraCT Number )
First Posted: October 21, 2009    Key Record Dates
Results First Posted: March 2, 2016
Last Update Posted: July 17, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Grazoprevir
Antiviral Agents
Anti-Infective Agents