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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Comparator: MK0633

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751413

MK0633-023

2008_529

0633-023

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

1

Experimental group

Description:

MK0633

Treatment:

Drug: Comparator: MK0633