Status:
COMPLETED
Staccato Loxapine Thorough QT/QTc Study
Lead Sponsor:
Alexza Pharmaceuticals, Inc.
Conditions:
Thorough QT/QTc Study
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.
Detailed Description
Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteer...
Eligibility Criteria
Inclusion
- Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.
Exclusion
- Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
- Subjects who have had an acute illness within the last 5 days of treatment,
- Subjects who are smokers, OR
- Subjects who have an ECG abnormality at baseline.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00874237
Start Date
April 1 2009
End Date
June 1 2009
Last Update
October 30 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States, 47710