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NCT00543062 · ClinicalTrials.gov registry record · Phase 1
Staccato Prochlorperazine Thorough QT/QTc
A Phase 1 study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00543062: Completed Phase 1 study, sponsored by Alexza Pharmaceuticals.
NCT00543062 is a Phase 1 study that has completed, run by Alexza Pharmaceuticals. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00543062, a Phase 1 study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
Primary Outcome
Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for treatment at 11 post-inhalation times.
Interventions
- DRUG Oral placebo
- DRUG Inhaled placebo
- DRUG Oral moxifloxacin
- DRUG Inhaled prochlorperazine 5 mg
- DRUG Inhaled prochlorperazine 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2007-10 |
| Est. Completion | 2007-12 |
| Phase | Phase 1 |
What the finished NCT00543062 record still lists
NCT00543062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 5 interventions - of which Oral placebo is the first listed.
NCT00543062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00543062 about?
NCT00543062 is a clinical study titled "Staccato Prochlorperazine Thorough QT/QTc". To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
What is the current status of trial NCT00543062?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2007-10. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00543062?
The interventions under investigation include: Oral placebo (DRUG), Inhaled placebo (DRUG), Oral moxifloxacin (DRUG), Inhaled prochlorperazine 5 mg (DRUG), Inhaled prochlorperazine 10 mg (DRUG).
Who is sponsoring clinical trial NCT00543062?
This trial is sponsored by Alexza Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00543062's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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