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A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-8325
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, Chronic

Eligibility Criteria

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

Inclusion criteria:

  • Body mass index (BMI) of 18 to ≤37 kg/m^2
  • Diagnosis of chronic HCV infection
  • Must be infected with HCV GT1a, GT1b, or GT3

Exclusion criteria:

  • Co-infection with GT1 and GT3 HCV
  • History of stroke, chronic seizures, or major neurological disorder
  • History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
  • History of neoplastic disease
  • Positive Hepatitis B surface antigen
  • History of human immunodeficiency virus (HIV) infection or positive HIV serology
  • Major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior
  • History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months
  • Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, autoimmune hepatitis
  • Previous treatments(s) with nonstructural 5A (NS5A) protein inhibitors
  • Treatment with protease inhibitor(s) <30 days prior to study enrollment
  • Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of MK-8325 in the study
  • Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy

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 Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Panel A (GT1 10 mg)

    Panel B (GT1 50 mg)

    Panel C (GT1 100 mg)

    Panel D (GT1 200 mg)

    Panel E (GT3 10 mg)

    Panel F (GT3 50 mg)

    Panel G (GT3 100 mg)

    Panel H (GT3 200 mg)

    Panel I (GT1a 10 mg)

    Panel J (GT1a 50 mg)

    Placebo Panel

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants
    Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
    Number of participants experiencing at least one adverse event
    Number of participants discontinuing study drug due to an adverse event

    Secondary Outcome Measures

    Trough plasma concentration (C24hr) of MK-8325
    Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325
    Maximum plasma concentration (Cmax) of MK-8325

    Full Information

    First Posted
    March 12, 2012
    Last Updated
    July 20, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01554189
    Brief Title
    A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)
    Official Title
    A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C Infected Males
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (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 study is being done to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-8325 in male hepatitis C virus (HCV)-infected participants. There will be 3 parts to this study. Part I will enroll only genotype 1 (GT1) HCV patients, Part II will enroll only genotype 3 (GT3) HCV-infected participants, and Part III will enroll only GT1a HCV-infected participants. All parts may run concurrently, or may be staggered as needed by the clinical sites.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Panel A (GT1 10 mg)
    Arm Type
    Experimental
    Arm Title
    Panel B (GT1 50 mg)
    Arm Type
    Experimental
    Arm Title
    Panel C (GT1 100 mg)
    Arm Type
    Experimental
    Arm Title
    Panel D (GT1 200 mg)
    Arm Type
    Experimental
    Arm Title
    Panel E (GT3 10 mg)
    Arm Type
    Experimental
    Arm Title
    Panel F (GT3 50 mg)
    Arm Type
    Experimental
    Arm Title
    Panel G (GT3 100 mg)
    Arm Type
    Experimental
    Arm Title
    Panel H (GT3 200 mg)
    Arm Type
    Experimental
    Arm Title
    Panel I (GT1a 10 mg)
    Arm Type
    Experimental
    Arm Title
    Panel J (GT1a 50 mg)
    Arm Type
    Experimental
    Arm Title
    Placebo Panel
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MK-8325
    Intervention Description
    MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo to match MK-8325 capsules, orally, once per day for 5 days
    Primary Outcome Measure Information:
    Title
    Change from baseline to Day 5 in plasma HCV ribonucleic acid (RNA) in GT1 participants
    Time Frame
    Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.
    Title
    Mean maximum reduction from baseline through Day 5 in HCV ribonucleic acid (RNA) in GT3 participants
    Time Frame
    Day 1 predose and 2, 4, 8, 12, 24 and 36 hours post-dose, Days 3 and 4 predose, Day 5 predose and 2, 4, 8, 12, and 24 hours post-dose.
    Title
    Number of participants experiencing at least one adverse event
    Time Frame
    Day 1 up to 56 days
    Title
    Number of participants discontinuing study drug due to an adverse event
    Time Frame
    Days 1-5
    Secondary Outcome Measure Information:
    Title
    Trough plasma concentration (C24hr) of MK-8325
    Time Frame
    Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose
    Title
    Area under the concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-8325
    Time Frame
    Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose
    Title
    Maximum plasma concentration (Cmax) of MK-8325
    Time Frame
    Day 1 predose and 0.25 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16 and 24 hours post-dose and Day 5 predose and 0.25, 0.5, 1, 2, 4, 5, 6, 7, 8, 12, 16, 24, 36,48, 72, 96, 120, 144, 168, 192, 216, and 240 hours post-dose

    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: Body mass index (BMI) of 18 to ≤37 kg/m^2 Diagnosis of chronic HCV infection Must be infected with HCV GT1a, GT1b, or GT3 Exclusion criteria: Co-infection with GT1 and GT3 HCV History of stroke, chronic seizures, or major neurological disorder History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases History of neoplastic disease Positive Hepatitis B surface antigen History of human immunodeficiency virus (HIV) infection or positive HIV serology Major surgery, donated or lost 1 unit of blood (approximately 500 mL) or participated in another investigational study within 4 weeks prior History of significant multiple and/or severe allergies (including latex allergy), or anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, autoimmune hepatitis Previous treatments(s) with nonstructural 5A (NS5A) protein inhibitors Treatment with protease inhibitor(s) <30 days prior to study enrollment Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to the first dose of MK-8325 in the study Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-8325 in Hepatitis C-Infected Males (MK-8325-002)

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