NCT00751413CompletedPhase 1
A Multicenter, Open-Label, Single Dose Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 6 to Less Than 12 Years
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 22
- Primary Endpoint
- To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
Study Overview
Brief Summary
To evaluate the safety, tolerability and plasma levels of single oral doses of MK0633 in pediatric asthma patients ages 6 to less than 12 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient has mild to moderate asthma
- •Patient is able to swallow pills
- •Patient is able to have have blood draws
Exclusion Criteria
- •Patient has required a visit to the hospital or emergency room due to an asthmatic event in the last 3 months
- •Patient has an upper respiratory tract infection (URI)
- •Patient has a history of stroke
- •Patient consumes more than 4 caffeinated beverages per day
Arms & Interventions
1
Experimental
MK0633
Intervention: Comparator: MK0633 (Drug)
Outcomes
Primary Outcomes
To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
Time Frame: Physical examinations, vital sign measurements, laboratory safety tests (blood chemistry, hematology and urinalysis), urine ß-hCG test, and 12-lead ECGs will be performed at various scheduled time points throughout the study.
Secondary Outcomes
- To obtain information on plasma pharmacokinetics (e.g., AUC0-inf, Cmax, Tmax, apparent t½,) of MK0633 after a single oral dose administration in pediatric asthma patients(Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.)
Investigators
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