search
Back to results

Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK-1075
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)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female of non-child bearing potential
  • In good health other than HCV genotype (GT) 1 infection

Exclusion Criteria:

  • Is mentally incapacitated or legally institutionalized
  • Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
  • Has a history of cancer
  • Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)
  • Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening
  • Consumes >2 alcoholic beverages a day or uses illegal drugs
  • Has 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, or autoimmune hepatitis
  • Has 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 Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    MK-1075 100 mg (Panel A)

    MK-1075 200 mg (Panel B)

    MK-1075 400 mg (Panel C)

    MK-1075 800 mg (Panel D)

    Arm Description

    HCV-infected participants receive a single 100 mg dose of MK-1075.

    HCV-infected participants receive a single 200 mg dose of MK-1075.

    HCV-infected participants receive a single 400 mg dose of MK-1075.

    HCV-infected participants receive a single 800 mg dose of MK-1075.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Experiencing an Adverse Event (AE)
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.
    Percentage of Participants Who Discontinued Study Due to an AE
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.
    Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075
    For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2015
    Last Updated
    January 7, 2019
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02392494
    Brief Title
    Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
    Official Title
    A Single Rising Dose Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MK-1075 in HCV-Infected Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 28, 2015 (Actual)
    Primary Completion Date
    August 10, 2015 (Actual)
    Study Completion Date
    August 10, 2015 (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
    The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.
    Detailed Description
    Per protocol, panels may be omitted if the objectives of the study are met in preceding panels.

    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
    Sequential Assignment
    Model Description
    In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MK-1075 100 mg (Panel A)
    Arm Type
    Experimental
    Arm Description
    HCV-infected participants receive a single 100 mg dose of MK-1075.
    Arm Title
    MK-1075 200 mg (Panel B)
    Arm Type
    Experimental
    Arm Description
    HCV-infected participants receive a single 200 mg dose of MK-1075.
    Arm Title
    MK-1075 400 mg (Panel C)
    Arm Type
    Experimental
    Arm Description
    HCV-infected participants receive a single 400 mg dose of MK-1075.
    Arm Title
    MK-1075 800 mg (Panel D)
    Arm Type
    Experimental
    Arm Description
    HCV-infected participants receive a single 800 mg dose of MK-1075.
    Intervention Type
    Drug
    Intervention Name(s)
    MK-1075
    Intervention Description
    MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Experiencing an Adverse Event (AE)
    Description
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.
    Time Frame
    Up to Study Day 14
    Title
    Percentage of Participants Who Discontinued Study Due to an AE
    Description
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.
    Time Frame
    Up to Study Day 14
    Title
    Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075
    Description
    For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.
    Time Frame
    Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female of non-child bearing potential In good health other than HCV genotype (GT) 1 infection Exclusion Criteria: Is mentally incapacitated or legally institutionalized Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases Has a history of cancer Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV) Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening Consumes >2 alcoholic beverages a day or uses illegal drugs Has 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, or autoimmune hepatitis Has 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
    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
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)

    We'll reach out to this number within 24 hrs