Staccato Loxapine Multidose PK

Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00555412

Enrollment

Registered

2007-11-08

Start date

2007-10-31

Completion date

2007-12-31

Last updated

2017-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Volunteers on Chronic, Stable Antipsychotic Regimens

Keywords

pharmacokinetic, multidose, Staccato Loxapine

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.

Interventions

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

loxapine aerosol inhalation high dose regimen (30 mg total)

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

loxapine aerosol inhalation middle dose regimen (20 mg total)

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

loxapine aerosol inhalation low dose regimen (15 mg total)

DRUGD - inhaled placebo q 4 h x 3

placebo aerosol inhalation (0 mg total)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

include: 1. Male and female subjects between the ages of 18 to 65 years, inclusive. 2. 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.

Exclusion criteria

include: 1. Subjects who are currently treated with injectable depot neuroleptics within one dose interval must be excluded. 2. Subjects who have received loxapine or amoxapine within the last 30 days must be excluded. 3. Subjects with a history of allergy or intolerance to dibenzoxazepines (loxapine and amoxapine) must be excluded. 4. Subjects with a history of movement disorders including Parkinson's disease or a history of neuroleptic malignant syndrome must be excluded. 5. Subjects who have a history within the past year of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026