At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
Inhaled placebo +4 moredrug
Likely dose
Inhaled prochlorperazine 5 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® Prochlorperazine for Inhalation in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating Inhaled placebo, Oral placebo, and 3 other interventions for Cardiotoxicity. Completed, enrolled 48 participants across 1 site.
Detailed Summary
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiotoxicity
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedOct 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedOct 12, 2007
Enrollment StartOct 1, 2007
Primary CompletionDec 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.7 years ago
Interventions
Inhaled placebodrug
Inhaled Staccato placebo (0 mg)
Oral placebodrug
Oral placebo (identical to 400 mg moxifloxacin)
Inhaled prochlorperazine 5 mgdrug
Staccato prochlorperazine 5 mg, single dose
Inhaled prochlorperazine 10 mgdrug
Inhaled prochlorperazine 10 mg, single dose
Oral moxifloxacindrug
Oral moxifloxacin 400 mg, si/ngle dose