Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
12-16 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability and pharmacokinetics (PK) of MK0633 in adolescent mild-to-moderate 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 and for 90 days after the last dose of study drug
- 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, Singulair (montelukast), Xolair (omalizumab), Zyflo amd Zyflo CR (zileuton), oral corticosteroids and oral beta agonists are excluded approximately 2 weeks prior to administration of study drug and throughout the study
- Patient consumes alcoholic beverages
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00646789
Start Date
May 1 2008
End Date
July 1 2008
Last Update
June 1 2015
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