NCT00751413

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Aug 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

5 months

First QC Date

September 11, 2008

Last Update Submit

May 29, 2015

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (1)

1

EXPERIMENTAL

MK0633

Drug: Comparator: MK0633

Interventions

Comparator: MK0633DRUG

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

1

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

August 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 1, 2015

Record last verified: 2015-05