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Staccato Loxapine Multidose PK

NCT00555412 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-15

No results posted yet for this study

Summary

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

Conditions

  • Volunteers on Chronic, Stable Antipsychotic Regimens

Interventions

DRUG

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

loxapine aerosol inhalation high dose regimen (30 mg total)

DRUG

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

loxapine aerosol inhalation middle dose regimen (20 mg total)

DRUG

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

loxapine aerosol inhalation low dose regimen (15 mg total)

DRUG

D - inhaled placebo q 4 h x 3

placebo aerosol inhalation (0 mg total)

Sponsors & Collaborators

  • Atlanta Center for Medical Research

    collaborator UNKNOWN

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Riesenberg, MD · Atlanta Center for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-12-31
Completion
2007-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555412 on ClinicalTrials.gov