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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MK0633

Group Type EXPERIMENTAL

Comparator: MK0633

Intervention Type DRUG

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

Interventions

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Comparator: MK0633

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No