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To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Samatasvir
Omeprazole
Ritonavir
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, antiviral drugs, liver

Eligibility Criteria

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

Inclusion Criteria:

  • Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
  • All participants of childbearing potential must agree 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.

Exclusion Criteria:

  • Pregnant or breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Samatasvir + Ritonavir

    Samatasvir + Omeprazole

    Arm Description

    Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water.

    Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke.

    Outcomes

    Primary Outcome Measures

    Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration
    Pharmacokinetic parameter: AUC from time zero to infinity
    Pharmacokinetic parameter: Maximum observed drug concentration (Cmax)

    Secondary Outcome Measures

    Percentage of participants who experienced at least one serious adverse event
    Percentage of participants who experienced at least one adverse event
    Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality

    Full Information

    First Posted
    March 13, 2013
    Last Updated
    January 21, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01813552
    Brief Title
    To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)
    Official Title
    A Phase I, Randomized, Open-label Study to Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of IDX719 in Healthy Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2013 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 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
    This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.

    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, 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
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Samatasvir + Ritonavir
    Arm Type
    Experimental
    Arm Description
    Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water.
    Arm Title
    Samatasvir + Omeprazole
    Arm Type
    Experimental
    Arm Description
    Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke.
    Intervention Type
    Drug
    Intervention Name(s)
    Samatasvir
    Intervention Description
    Samatasvir 150 mg oral tablets (50mg x 3), single dose
    Intervention Type
    Drug
    Intervention Name(s)
    Omeprazole
    Intervention Description
    40 mg delayed-release oral capsules, once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Ritonavir
    Intervention Description
    100 mg oral tablets, once daily
    Primary Outcome Measure Information:
    Title
    Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration
    Time Frame
    0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
    Title
    Pharmacokinetic parameter: AUC from time zero to infinity
    Time Frame
    0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
    Title
    Pharmacokinetic parameter: Maximum observed drug concentration (Cmax)
    Time Frame
    0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
    Secondary Outcome Measure Information:
    Title
    Percentage of participants who experienced at least one serious adverse event
    Time Frame
    Up to 17 days
    Title
    Percentage of participants who experienced at least one adverse event
    Time Frame
    Up to 17 days
    Title
    Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality
    Time Frame
    Up to 17 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: Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained. All participants of childbearing potential must agree 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. Exclusion Criteria: Pregnant or breastfeeding.
    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

    To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

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