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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Grazoprevir
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm 11

    Arm 12

    Arm 13

    Arm 14

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    400 mg Grazoprevir - GT1

    600 mg Grazoprevir - GT1

    800 mg Grazoprevir - GT1

    400 mg Grazoprevir - GT3

    600 mg Grazoprevir - GT3

    800 mg Grazoprevir - GT3

    200 mg Grazoprevir - GT1

    100 mg Grazoprevir - GT1

    50 mg Grazoprevir - GT1

    200 mg Grazoprevir - GT3

    100 mg Grazoprevir - GT3

    50 mg Grazoprevir - GT3

    30 mg Grazoprevir - GT1

    10 mg Grazoprevir - GT1

    Arm Description

    GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo

    GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo

    GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo

    GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo

    GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo

    GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo

    GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo

    GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo

    Outcomes

    Primary Outcome Measures

    Number of Participants With Clinical and Laboratory Adverse Events (AEs)
    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

    Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7
    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
    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
    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
    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.

    Full Information

    First Posted
    October 20, 2009
    Last Updated
    June 19, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00998985
    Brief Title
    A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
    Official Title
    A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Grazoprevir (MK-5172) in Hepatitis C Infected Male Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 23, 2010 (Actual)
    Primary Completion Date
    November 8, 2012 (Actual)
    Study Completion Date
    November 8, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    400 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo
    Arm Title
    600 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo
    Arm Title
    800 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo
    Arm Title
    400 mg Grazoprevir - GT3
    Arm Type
    Experimental
    Arm Description
    GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo
    Arm Title
    600 mg Grazoprevir - GT3
    Arm Type
    Experimental
    Arm Description
    GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo
    Arm Title
    800 mg Grazoprevir - GT3
    Arm Type
    Experimental
    Arm Description
    GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo
    Arm Title
    200 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo
    Arm Title
    100 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo
    Arm Title
    50 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo
    Arm Title
    200 mg Grazoprevir - GT3
    Arm Type
    Experimental
    Arm Description
    GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo
    Arm Title
    100 mg Grazoprevir - GT3
    Arm Type
    Experimental
    Arm Description
    GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo
    Arm Title
    50 mg Grazoprevir - GT3
    Arm Type
    Experimental
    Arm Description
    GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo
    Arm Title
    30 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo
    Arm Title
    10 mg Grazoprevir - GT1
    Arm Type
    Experimental
    Arm Description
    GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Grazoprevir
    Intervention Description
    10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablet, orally, once a day for 7 days
    Primary Outcome Measure Information:
    Title
    Number of Participants With Clinical and Laboratory Adverse Events (AEs)
    Description
    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.
    Time Frame
    All AEs: 15 Days after last dose; Serious AEs (SAEs) up to 2 months after last dose (Up to 67 days)
    Secondary Outcome Measure Information:
    Title
    Area Under the Curve for 0 to 24 Hours Post-dose (AUC[0-24hr]) of Grazoprevir on Day 7
    Description
    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.
    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
    Title
    24 Hour Plasma Concentration (C[24hr]) of Grazoprevir on Day 7
    Description
    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.
    Time Frame
    Day 7 at 24 hours post-dose
    Title
    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
    Description
    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.
    Time Frame
    Baseline and up to approximately 2 months
    Title
    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
    Description
    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.
    Time Frame
    Baseline and up to approximately 2 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    29703432
    Citation
    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.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=5172-004&kw=5172-004&tab=access

    Learn more about this trial

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

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