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NCT00874237 · ClinicalTrials.gov registry record · Phase 1
Staccato Loxapine Thorough QT/QTc Study
A Phase 1 study of Thorough QT/QTc Study, sponsored by Alexza Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT00874237: Completed Phase 1 study of Thorough QT/QTc Study, sponsored by Alexza Pharmaceuticals.
NCT00874237 is a Phase 1 study of Thorough QT/QTc 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). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00874237, a Phase 1 study of Thorough QT/QTc Study, has completed, sponsored by Alexza Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Largest of the upper CIs of the 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 ADASUVE treatment at 12 prespecified post inhalation times
Conditions Studied
Interventions
- DRUG Oral placebo
- DRUG Inhaled loxapine
- DRUG Inhaled placebo
- DRUG Oral moxifloxacin
Study Locations (1)
Indiana
- Covance Clinical Research Unit Inc. - Evansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
What the finished NCT00874237 record still lists
NCT00874237 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 1 condition, with Thorough QT/QTc Study appearing as the primary indexed condition, and to 4 interventions - of which Oral placebo is the first listed.
NCT00874237 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT00874237 about?
NCT00874237 is a clinical study titled "Staccato Loxapine Thorough QT/QTc Study". 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.
What is the current status of trial NCT00874237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2009-04. Estimated completion is 2009-06.
What conditions does trial NCT00874237 study?
This clinical trial studies the following conditions: Thorough QT/QTc Study.
What interventions are being tested in trial NCT00874237?
The interventions under investigation include: Oral placebo (DRUG), Inhaled loxapine (DRUG), Inhaled placebo (DRUG), Oral moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT00874237?
This trial is sponsored by Alexza Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00874237 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00874237'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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