Status:
COMPLETED
MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
12-15 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00768170
Start Date
September 1 2008
End Date
May 1 2009
Last Update
July 3 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.