Phase 1
Completed N=48
Staccato Loxapine Thorough QT/QTc Study
Thorough QT/QTc Study
Source: ClinicalTrials.gov NCT00874237 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo — 5.418 mseconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo |
5.418 | — |
| SECONDARY Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers. |
4.238 | — |
| SECONDARY Numbers and % of Subjects With QTcI > 450 ms |
1; 1 | — |
| SECONDARY Numbers and % of Subjects With QTcI > 480 ms |
0; 0 | — |
| SECONDARY Numbers and % of Subjects With QTcI Change > 30 ms |
1; 1 | — |
| SECONDARY Numbers and % of Subjects With QTcI Change > 60 ms |
0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00874237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.