A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK0476 in Patients With Mild or Moderate Asthma.
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); Comparator: placebo (unspecified) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled MK0476 in
patients with mild or moderate asthma.
Clinical Details
Official title: A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild of Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK0476
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Evaluate the safety and tolerability of inhaled doses of MK0476.
Secondary outcome: Evaluate the plasma pharmacokinetic data of inhaled doses of MK0476.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male of female between the ages of 18 and 65
- Must have mild or moderate asthma
- Nonsmoker for at least 6 months
Exclusion Criteria:
- History of stroke, chronic seizures or major neurological disorder
- You are nursing
- Drink more than 3 glasses of alcohol a day
- Have allergy to or not able to tolerate milk of lactose
- Have a history of drug abuse in the last 5 years
- Drink more than 6 beverages containing caffeine a day
- Have had surgery, donated blood or participated in another investigational study in
the last 4 weeks
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Cypress, California 90630, United States; Recruiting
Call for Information, Evansville, Indiana 47714, United States; Recruiting
Call for Information, Knoxville, Tennessee 37920, United States; Recruiting
Additional Information
MedWatch - FDA maintained medical product safety Information PhRMA Clinical Study Results Database - web-based repository for clinical study results Merck: Patient & Caregiver U.S. Product Web Site
Starting date: October 2007
Last updated: January 8, 2009
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