clinical trial · NCT00874237
Staccato Loxapine Thorough QT/QTc Study
Nova Pneuma Inc.·phase1·completed·n = 48
Thorough QT/QTc StudyInhaled loxapineInhaled placeboOral moxifloxacinOral placebo
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.
started
Apr 1, 2009
primary completion
Jun 1, 2009
completion
Jun 1, 2009
last updated
Apr 22, 2026
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 volunteers.
Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers.
official title
Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol