Who is sponsoring NCT00444028?

NCT00444028 is sponsored by Alexza Pharmaceuticals, Inc..

What condition does NCT00444028 study?

NCT00444028 studies Schizophrenia.

What drugs are being tested in NCT00444028?

Interventions: inhaled Loxapine 0.625 mg, inhaled Loxapine 1.25 mg, inhaled Loxapine 2.5 mg, inhaled Loxapine 5 mg, inhaled Loxapine 10 mg, inhaled Placebo (0 mg).

What is the status of NCT00444028?

NCT00444028 is currently COMPLETED.

Last reviewed 2018-11-17 · How we verify

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

NCT00444028 Phase 1 COMPLETED Results posted

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.

Details

Lead sponsor	Alexza Pharmaceuticals, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	50
Start date	2005-09
Completion	2005-11

Conditions

Schizophrenia

Interventions

inhaled Loxapine 0.625 mg
inhaled Loxapine 1.25 mg
inhaled Loxapine 2.5 mg
inhaled Loxapine 5 mg
inhaled Loxapine 10 mg
inhaled Placebo (0 mg)

Primary outcomes

Tmax — predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Tmax = time from inhalation to to maximum observed loxapine concentration
Half-life — predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Half-life of the terminal elimination phase of loxapine concentrations
ke — predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
elimination rate constant
Clearance — predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
clearance (CL/F) of lozxapine
Cmax — predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
maximum concentration of loxapine observed
Dose Proportionality (AUCinf) by Power Analysis — predose, 0.5, 1, 2, 3, 5, 10, 30 and 45 min, 1, 2, 4, 6, 12, and 24 hours
Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being "perfect". Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is "as good as it gets".

Countries

United States