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Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX719
Simeprevir
TMC647055
RTV
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 focused on measuring Chronic hepatitis C, Hepatitis C virus, HCV

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug
  • Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug

Exclusion Criteria:

  • Is pregnant or breastfeeding
  • Has another clinically significant medical conditions or laboratory abnormality(s)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    IDX719 + RTV

    Simeprevir/TMC647055 + RTV

    Arm Description

    Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.

    Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.

    Outcomes

    Primary Outcome Measures

    Observed maximum plasma drug concentration (Cmax)
    Time to maximum concentration (Tmax)
    Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
    Predose trough concentration (Ctrough)
    Apparent terminal elimination rate constant
    Observed terminal half-life (T1/2)

    Secondary Outcome Measures

    Percentage of participants experiencing serious adverse events (SAEs)
    Percentage of participants experiencing adverse events (AEs)
    Percentage of participants with Grade 1-4 laboratory abnormalities

    Full Information

    First Posted
    June 4, 2013
    Last Updated
    January 25, 2016
    Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01907724
    Brief Title
    Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)
    Official Title
    A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC
    Collaborators
    Janssen Research & Development, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the potential for a PK drug-drug interaction when IDX719, simeprevir, TMC647055 and low-dose ritonavir (RTV) are administered in combination. Safety and tolerability will also be assessed.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    34 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IDX719 + RTV
    Arm Type
    Experimental
    Arm Description
    Participants take IDX719 150 mg once daily (QD) + ritonavir 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
    Arm Title
    Simeprevir/TMC647055 + RTV
    Arm Type
    Experimental
    Arm Description
    Participants take simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 1-7, and then take IDX719 150 mg QD + simeprevir 75 mg QD + TMC647055 450 mg QD + RTV 30 mg QD on Days 8-14.
    Intervention Type
    Drug
    Intervention Name(s)
    IDX719
    Intervention Description
    IDX719 will be supplied as a 50 mg tablet for oral administration.
    Intervention Type
    Drug
    Intervention Name(s)
    Simeprevir
    Other Intervention Name(s)
    Olysio™
    Intervention Description
    Simeprevir will be supplied as 75 mg capsules for oral administration.
    Intervention Type
    Drug
    Intervention Name(s)
    TMC647055
    Intervention Description
    TMC647055 will be supplied as 150 mg capsules for oral administration.
    Intervention Type
    Drug
    Intervention Name(s)
    RTV
    Other Intervention Name(s)
    Norvir™
    Intervention Description
    RTV will be supplied as 80 mg/mL solution for oral administration.
    Primary Outcome Measure Information:
    Title
    Observed maximum plasma drug concentration (Cmax)
    Time Frame
    Up to 14 days
    Title
    Time to maximum concentration (Tmax)
    Time Frame
    Up to 14 days
    Title
    Area under the drug concentration-plasma time curve from time zero to last measurable concentration (AUC0-t)
    Time Frame
    Up to 14 days
    Title
    Predose trough concentration (Ctrough)
    Time Frame
    Up to 14 days
    Title
    Apparent terminal elimination rate constant
    Time Frame
    Up to 14 days
    Title
    Observed terminal half-life (T1/2)
    Time Frame
    Up to 14 days
    Secondary Outcome Measure Information:
    Title
    Percentage of participants experiencing serious adverse events (SAEs)
    Time Frame
    Up to 28 days
    Title
    Percentage of participants experiencing adverse events (AEs)
    Time Frame
    Up to 28 days
    Title
    Percentage of participants with Grade 1-4 laboratory abnormalities
    Time Frame
    Up to 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug Male participants agree not to donate sperm from Day -1 through 90 days after the last dose of study drug Exclusion Criteria: Is pregnant or breastfeeding Has another clinically significant medical conditions or laboratory abnormality(s)
    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

    Learn more about this trial

    Drug-Drug Interaction Between IDX719, Simeprevir, TMC647055 and Ritonavir When Administered in Combination in Healthy Participants (MK-1894-007)

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