Trials Sponsors Conditions Drugs Pricing

Conditions

Volunteers on Chronic, Stable Antipsychotic Regimens

Keywords

pharmacokineticmultidoseStaccato Loxapine

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

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

Study Arms (4)

A - 10 mg loxapine q 4 h x 3 (30 mg total)

EXPERIMENTAL

Drug: A - 10 mg loxapine q 4 h x 3 (30 mg total)

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

EXPERIMENTAL

Drug: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

C - 5 mg loxapine q 4 h x 3 (15 mg total)

EXPERIMENTAL

Drug: C - 5 mg loxapine q 4 h x 3 (15 mg total)

Interventions

A - 10 mg loxapine q 4 h x 3 (30 mg total)Drug

loxapine aerosol inhalation high dose regimen (30 mg total)

Also known as: Staccato Loxapine 10 mg

A - 10 mg loxapine q 4 h x 3 (30 mg total)

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)Drug

loxapine aerosol inhalation middle dose regimen (20 mg total)

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects between the ages of 18 to 65 years, inclusive.
Subjects who are on stable, oral, chronic (\>2 mos) antipsychotic medication regimen and who are able to tolerate the rapid oral dose taper and substitution regimen.

Sponsors & Collaborators

Atlanta Center for Medical Research
Type not reportedcollaborator
Alexza Pharmaceuticals, Inc.
Type not reportedlead

Study Sites (1)

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Related Publications (1)

Spyker DA, Riesenberg RA, Cassella JV. Multiple dose pharmacokinetics of inhaled loxapine in subjects on chronic, stable antipsychotic regimens. J Clin Pharmacol. 2015 Sep;55(9):985-94. doi: 10.1002/jcph.502. Epub 2015 May 6.
PMID: 25808074BACKGROUND

Study Officials

Robert Riesenberg, MD
Atlanta Center for Medical Research
PRINCIPAL INVESTIGATOR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: UNKNOWN
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 8, 2007

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

Staccato Loxapine Multidose PK

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

A - 10 mg loxapine q 4 h x 3 (30 mg total)

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

C - 5 mg loxapine q 4 h x 3 (15 mg total)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

D - inhaled placebo q 4 h x 3

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (4)

A - 10 mg loxapine q 4 h x 3 (30 mg total)

B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)

C - 5 mg loxapine q 4 h x 3 (15 mg total)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

D - inhaled placebo q 4 h x 3

You may not qualify if:

Data Sharing

Source record

Locations