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

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

3 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-0476, montelukast sodium

Drug

Duration of Treatment: 14 Days

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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Randomized, 3-Period, Multiple-Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Plasma Concentration Profile of Montelukast Administered Once Daily as Oral Granules in Children Aged 3 to 6 Months

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2003
First posted: Oct 31, 2006
Registry last updated: Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed