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Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX719
Simeprevir
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring HCV, Hepatitis C Virus, Hepatitis C, antiviral drugs, liver

Eligibility Criteria

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

Inclusion Criteria:

  • Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
  • 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 study drug
  • Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study

Exclusion Criteria:

  • Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
  • Is pregnant or breastfeeding
  • Has previously received either IDX719 or simeprevir
  • Has participated in another clinical drug study within 30 days of Screening

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A: IDX719 then IDX719/Simeprevir

    Group B: Simeprevir then IDX719/Simeprevir

    Group C: IDX719

    Group D: IDX719/Simeprevir

    Group E: High-Fat then Low-Fat PK

    Group F: Low-Fat then High-Fat PK

    Arm Description

    Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.

    Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.

    Healthy participants take IDX719 150 mg QD on Days 1-14.

    Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.

    Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).

    Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).

    Outcomes

    Primary Outcome Measures

    Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
    Maximum observed plasma concentration (Cmax)
    AUC from time zero to infinity
    Trough plasma concentration (Ctrough)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 13, 2013
    Last Updated
    January 25, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01813513
    Brief Title
    Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
    Official Title
    A Phase I, Randomized, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 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
    The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C Infection
    Keywords
    HCV, Hepatitis C Virus, Hepatitis C, antiviral drugs, liver

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: IDX719 then IDX719/Simeprevir
    Arm Type
    Experimental
    Arm Description
    Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
    Arm Title
    Group B: Simeprevir then IDX719/Simeprevir
    Arm Type
    Experimental
    Arm Description
    Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14.
    Arm Title
    Group C: IDX719
    Arm Type
    Experimental
    Arm Description
    Healthy participants take IDX719 150 mg QD on Days 1-14.
    Arm Title
    Group D: IDX719/Simeprevir
    Arm Type
    Experimental
    Arm Description
    Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.
    Arm Title
    Group E: High-Fat then Low-Fat PK
    Arm Type
    Experimental
    Arm Description
    Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout).
    Arm Title
    Group F: Low-Fat then High-Fat PK
    Arm Type
    Experimental
    Arm Description
    Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout).
    Intervention Type
    Drug
    Intervention Name(s)
    IDX719
    Other Intervention Name(s)
    Samatasvir
    Intervention Description
    50 mg tablet for oral administration
    Intervention Type
    Drug
    Intervention Name(s)
    Simeprevir
    Other Intervention Name(s)
    Olysio™
    Intervention Description
    150 mg capsule for oral administration
    Primary Outcome Measure Information:
    Title
    Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss)
    Time Frame
    Up to 30 days
    Title
    Maximum observed plasma concentration (Cmax)
    Time Frame
    Up to 30 days
    Title
    AUC from time zero to infinity
    Time Frame
    Up to 30 days
    Title
    Trough plasma concentration (Ctrough)
    Time Frame
    Up to 30 days
    Secondary Outcome Measure Information:
    Title
    Percentage of participants experiencing serious adverse events (SAEs)
    Time Frame
    Up to 30 days
    Title
    Percentage of participants experiencing adverse events (AEs)
    Time Frame
    Up to 30 days
    Title
    Percentage of participants experiencing Grade 1-4 laboratory abnormalities
    Time Frame
    Up to 30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG) 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 study drug Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study Exclusion Criteria: Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies Is pregnant or breastfeeding Has previously received either IDX719 or simeprevir Has participated in another clinical drug study within 30 days of Screening
    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

    Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)

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