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Staccato Loxapine Pulmonary Safety in Healthy Volunteers

NCT00789360 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-03-11

Study results available
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Summary

The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.

Conditions

  • Healthy

Interventions

DRUG

Inhaled Placebo

Inhaled Staccato Placebo, 2 inhalations, 8 hours apart

DRUG

Inhaled Loxapine

Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David S. Miller, MD · Northeast Medical Research, North Dartmouth, MA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2009-04-30
Completion
2009-04-30
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 NCT00789360 on ClinicalTrials.gov