CompletedPhase 1

Staccato Loxapine Thorough QT/QTc Study

United States48 participantsStarted 2009-04

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo

Timeframe: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours

Trial details

NCT IDNCT00874237

SponsorNova Pneuma Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-06

Results submitted2017-03-13

View on ClinicalTrials.gov More Thorough QT/QTc Study trials