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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: MK0633

Drug

A single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.

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

Time frame: Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Sep 12, 2008
Registry last updated: Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed