CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
inhaled Loxapine 0.625 mg +5 moredrug
Likely dose
inhaled Loxapine 0.625 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00444028
NCT00444028Phase 1Completed
CompareCT.gov

Safety, Tolerability, and Pharmacokinetics of a Single Dose of Staccato™ Loxapine for Inhalation in Normal, Healthy Volunteers

Alexza Pharmaceuticals, Inc.·interventional·Posted Mar 7, 2007·Updated Nov 20, 2018

In Brief

A Phase 1 clinical trial evaluating inhaled Loxapine 0.625 mg, inhaled Loxapine 1.25 mg, and 4 other interventions for Schizophrenia. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 7, 2007
Enrollment StartSep 1, 2005
Primary CompletionNov 1, 2005
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 19.3 years ago

Interventions

inhaled Loxapine 0.625 mgdrug

Single 0.625 mg (lowest) dose of inhaled loxapine

inhaled Loxapine 1.25 mgdrug

Single 1.25 mg (2nd) dose of inhaled loxapine

inhaled Loxapine 2.5 mgdrug

Single 2.5 mg (3rd) dose of inhaled loxapine

inhaled Loxapine 5 mgdrug

Single 5 mg (4th) dose of inhaled loxapine

inhaled Loxapine 10 mgdrug

Single 10 mg (5th) dose of inhaled loxapine

inhaled Placebo (0 mg)drug

Single placebo dose of inhaled loxapine