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MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MK0633
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests
  • Patient Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug
  • Patient Has At Least 1 Year Of Mild-To-Moderate Asthma
  • Patient Has Been A Nonsmoker For At Least 6 Months
  • Patients Of Childbearing Potential Must Agree To Use A Medically Acceptable Method Of Contraception During The Study
  • Patients Must Be Able To Swallow Tablets

Exclusion Criteria:

  • Patient Has A History Of Clinically Significant Endocrine, Gastrointestinal, Cardiovascular, Hematological, Hepatic, Immunological, Renal, Respiratory, Other Than Asthma, Or Genitourinary Abnormalities Or Diseases
  • Patient Has Required A Visit To A Hospital Or Emergency Room Due To An Asthma Exacerbation Within 3 Months Of The Prestudy Visit
  • Patient Has Unresolved Signs And Symptoms Of An Upper Respiratory Tract Infection (Uri) Or Has Had Had An Upper Respiratory Tract Infection Within 3 Weeks Prior To The Prestudy Visit
  • Patient Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder
  • Patient Has A History Of Neoplastic Disease
  • Use Of Theophylline, Anti-Allergic Compounds (Except For Nasal Drop And Eye-Drop Omalizumab, Zileuton, Oral Corticosteroid, And Oral Beta Agonists (Including Patch) Are Excluded ~ 2 Weeks Prior To Administration Of Study Drug And Throughout The Study 7)Patient Consumes Alcoholic Beverages

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    MK0633

    Outcomes

    Primary Outcome Measures

    To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2008
    Last Updated
    July 2, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00768170
    Brief Title
    MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)
    Official Title
    A Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK0633 in Japanese Asthmatic Children Aged 12 to Less Than 16 Years
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (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 evaluates the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate Japanese asthma patients to permit further clinical investigation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    MK0633
    Intervention Type
    Drug
    Intervention Name(s)
    MK0633
    Intervention Description
    MK0633 (50 mg) Oral, single dose
    Primary Outcome Measure Information:
    Title
    To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests Patient Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy (Screening) Visit And/Or Prior To Administration Of The Initial Dose Of Study Drug Patient Has At Least 1 Year Of Mild-To-Moderate Asthma Patient Has Been A Nonsmoker For At Least 6 Months Patients Of Childbearing Potential Must Agree To Use A Medically Acceptable Method Of Contraception During The Study Patients Must Be Able To Swallow Tablets Exclusion Criteria: Patient Has A History Of Clinically Significant Endocrine, Gastrointestinal, Cardiovascular, Hematological, Hepatic, Immunological, Renal, Respiratory, Other Than Asthma, Or Genitourinary Abnormalities Or Diseases Patient Has Required A Visit To A Hospital Or Emergency Room Due To An Asthma Exacerbation Within 3 Months Of The Prestudy Visit Patient Has Unresolved Signs And Symptoms Of An Upper Respiratory Tract Infection (Uri) Or Has Had Had An Upper Respiratory Tract Infection Within 3 Weeks Prior To The Prestudy Visit Patient Has A History Of Stroke, Chronic Seizures, Or Major Neurological Disorder Patient Has A History Of Neoplastic Disease Use Of Theophylline, Anti-Allergic Compounds (Except For Nasal Drop And Eye-Drop Omalizumab, Zileuton, Oral Corticosteroid, And Oral Beta Agonists (Including Patch) Are Excluded ~ 2 Weeks Prior To Administration Of Study Drug And Throughout The Study 7)Patient Consumes Alcoholic Beverages
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)

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