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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768170
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Asthma Drug: MK0633 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: MK0633
MK0633 (50 mg) Oral, single dose

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768170

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00768170     History of Changes
Other Study ID Numbers: 0633-028
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: July 2015