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

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751413
• Other study ID #: 0633-023
• Secondary ID: MK0633-0232008_5
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2008
• Last updated: May 29, 2015
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: May 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No