At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
Inhaled loxapine +3 moredrug
Likely dose
Inhaled loxapine 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Inhaled loxapine, Inhaled placebo, and 2 other interventions for Thorough QT/QTc Study. Completed, enrolled 48 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThorough QT/QTc Study
CountriesUnited States
CollaboratorsCovance
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedApr 2009
Primary CompletionJun 2009
TodayJul 2026
First PostedApr 2, 2009
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.3 years ago
Interventions
Inhaled loxapinedrug
Inhaled Staccato Loxapine 10 mg single dose
Inhaled placebodrug
Inhaled Staccato placebo single dose
Oral moxifloxacindrug
Oral moxifloxacin 400 mg
Oral placebodrug
Oral placebo similar in appearance to moxifloxacin 400 mg