Staccato Loxapine Multidose PK

Phase 1

Completed

• Conditions: Volunteers on Chronic, Stable Antipsychotic Regimens
• Interventions: Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total); Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total); Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total); Drug: D - inhaled placebo q 4 h x 3

• Registration Number: NCT00555412
• Lead Sponsor: Alexza Pharmaceuticals, Inc.

Brief Summary

The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.

Detailed Description

The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-08
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2013-06
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)	B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)	-
A - 10 mg loxapine q 4 h x 3 (30 mg total)	A - 10 mg loxapine q 4 h x 3 (30 mg total)	-
C - 5 mg loxapine q 4 h x 3 (15 mg total)	C - 5 mg loxapine q 4 h x 3 (15 mg total)	-
D - inhaled placebo q 4 h x 3	D - inhaled placebo q 4 h x 3	-

Primary Outcome Measures

Name	Time	Method
PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.	48 hours

Secondary Outcome Measures

Name	Time	Method
Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group	24 hours
Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.	24 hours

Trial Locations

Locations (1)

Atlanta Center for Medical Research; 🇺🇸 Atlanta, Georgia, United States