A Phase 1 interventional study of Comparator: MK0633 in Asthma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 6 Years to 11 Years. Per ClinicalTrials.gov, last updated 2015-06-01.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
MK0633
Drug: Comparator: MK0633
A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
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.
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
Time frame: Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.
No study locations are listed for this record.
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC