Asthma
Conditions
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.
Interventions
A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients. | 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
| Measure | Time frame |
|---|---|
| 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. |
Outcome results
None listed