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Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Primary Purpose

Chronic Hepatitis C

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
IDX21459
Matching Placebo
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 focused on measuring Hepatitis C virus, HCV

Eligibility Criteria

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

Inclusion Criteria:

All subjects

  • Subjects are in good general health.
  • Subjects have provided written informed consent form.
  • 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. HCV Subjects
  • Documented clinical history compatible with chronic hepatitis C without cirrhosis.
  • Treatment-naïve
  • HCV Genotype 1

Exclusion Criteria:

All subjects

  • Pregnant or breastfeeding
  • Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
  • Decompensated liver disease
  • 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

    Group A

    Group B

    Group C

    Arm Description

    Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days

    HCV subjects genotype 1, IDX21459 capsules, once for 1 day

    HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days

    Outcomes

    Primary Outcome Measures

    Safety and tolerability assessment
    Proportion of subjects experiencing adverse events.

    Secondary Outcome Measures

    Pharmacokinetic
    Plasma and urine concentrations of IDX21459 and its metabolite/s.

    Full Information

    First Posted
    April 10, 2014
    Last Updated
    January 25, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02112942
    Brief Title
    Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
    Official Title
    A Phase I Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    Early termination of IDX21459 was due to integration of Merck's HCV antiviral pipeline has resulted in revisions of the clinical development plan.
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 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
    A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    HCV subjects genotype 1, IDX21459 capsules, once for 1 day
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    IDX21459
    Intervention Type
    Drug
    Intervention Name(s)
    Matching Placebo
    Primary Outcome Measure Information:
    Title
    Safety and tolerability assessment
    Description
    Proportion of subjects experiencing adverse events.
    Time Frame
    up to 35 days
    Secondary Outcome Measure Information:
    Title
    Pharmacokinetic
    Description
    Plasma and urine concentrations of IDX21459 and its metabolite/s.
    Time Frame
    Up to 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
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: All subjects Subjects are in good general health. Subjects have provided written informed consent form. 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. HCV Subjects Documented clinical history compatible with chronic hepatitis C without cirrhosis. Treatment-naïve HCV Genotype 1 Exclusion Criteria: All subjects Pregnant or breastfeeding Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV). Decompensated liver disease Other clinically significant medical conditions or laboratory abnormalities.

    12. IPD Sharing Statement

    Learn more about this trial

    Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

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