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Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX719
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

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All subjects of childbearing potential must have agreed 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 subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Other clinically significant medical conditions or laboratory abnormalities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1: Child-Pugh Class A

    Cohort 2: Child-Pugh Class B

    Cohort 3: Child-Pugh Class C

    Arm Description

    Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1.

    Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1.

    Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1.

    Outcomes

    Primary Outcome Measures

    Maximum plasma concentration (Cmax)
    Time to maximum plasma concentration (Tmax)
    Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
    AUC from time zero to infinity (AUC0-~)
    AUC from time zero to 24 hours (AUC0-24h)
    Plasma concentration 24 hours after dosing (C24h)
    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 an adverse event (AE)
    Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Full Information

    First Posted
    August 6, 2013
    Last Updated
    January 25, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01919125
    Brief Title
    Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
    Official Title
    A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (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 pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1: Child-Pugh Class A
    Arm Type
    Experimental
    Arm Description
    Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
    Arm Title
    Cohort 2: Child-Pugh Class B
    Arm Type
    Experimental
    Arm Description
    Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
    Arm Title
    Cohort 3: Child-Pugh Class C
    Arm Type
    Experimental
    Arm Description
    Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1.
    Intervention Type
    Drug
    Intervention Name(s)
    IDX719
    Other Intervention Name(s)
    Samatasvir
    Intervention Description
    IDX719 supplied as 50 mg tablets.
    Primary Outcome Measure Information:
    Title
    Maximum plasma concentration (Cmax)
    Time Frame
    Up to 6 days
    Title
    Time to maximum plasma concentration (Tmax)
    Time Frame
    Up to 6 days
    Title
    Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
    Time Frame
    Up to 6 days
    Title
    AUC from time zero to infinity (AUC0-~)
    Time Frame
    Up to 6 days
    Title
    AUC from time zero to 24 hours (AUC0-24h)
    Time Frame
    Up to 6 days
    Title
    Plasma concentration 24 hours after dosing (C24h)
    Time Frame
    Up to 6 days
    Title
    Apparent terminal elimination rate constant
    Time Frame
    Up to 6 days
    Title
    Observed terminal half-life (T1/2)
    Time Frame
    Up to 6 days
    Secondary Outcome Measure Information:
    Title
    Percentage of participants experiencing serious adverse events (SAEs)
    Time Frame
    Up to 6 days
    Title
    Percentage of participants experiencing an adverse event (AE)
    Time Frame
    Up to 6 days
    Title
    Percentage of participants experiencing Grade 1-4 laboratory abnormalities
    Time Frame
    Up to 6 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained. All subjects of childbearing potential must have agreed 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 subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug. Exclusion Criteria: Pregnant or breastfeeding. Other clinically significant medical conditions or laboratory abnormalities
    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

    Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

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