PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)

Organon and Co14 enrolled

Overview

The purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bronchiolitis

Interventions

MK-0476, montelukast sodiumDRUG

Duration of Treatment: 14 Days

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria : * Active bronchiolitis or a history of bronchiolitis and asthma-like symptoms Exclusion Criteria : * A history of any significant illness that will pose additional risk to the patient

Outcomes

Primary Outcomes

To evaluate the safety and tolerability of montelukast oral granules in children aged 3 to 6 months.

Time frame: 14 days

Secondary Outcomes

To estimate the single-dose population pharmacokinetics, maximum plasma concentration, time to maximum plasma concentration, and apparent half-life of montelukast 4-mg oral granules in children aged 3 to 6 months.

Time frame: 24 hours

Data from ClinicalTrials.gov

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