Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)

Phase 1

Completed

• Conditions: Asthma

• Registration Number: NCT00751413
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-12
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Patient has mild to moderate asthma
• Patient is able to swallow pills
• Patient is able to have have blood draws

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.