Inhaled Drug's heart effects scrutinized in small safety trial
NCT ID NCT00874237
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This early-stage study tested whether a single inhaled dose of Staccato Loxapine affects the heart's electrical activity in 48 healthy adults. Participants received the drug, a placebo, and a control drug in random order, and their heart rhythms were measured. The goal was to check for heart-related side effects, not to treat any disease. The study found no major heart risks at the tested dose.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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48 people
The number who actually took part.
- Start date
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Apr 2009
- Finished
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Jun 2009
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study. Exclusion Criteria: * Subjects who have taken prescription or nonprescription medication within 5 days of treatment, * Subjects who have had an acute illness within the last 5 days of treatment, * Subjects who are smokers, OR * Subjects who have an ECG abnormality at baseline.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Covance Clinical Research Unit Inc.
Evansville, Indiana, 47710, United States