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Staccato Loxapine Single Dose PK

NCT00444028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-11-20

Study results available
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Summary

The objective of this study was to assess the safety, tolerability and pharmacokinetics of a single inhaled dose of (administered in 1 or 2 puffs) Staccato Loxapine in healthy volunteers.

Conditions

Interventions

DRUG

inhaled Loxapine 0.625 mg

Single 0.625 mg (lowest) dose of inhaled loxapine

DRUG

inhaled Loxapine 1.25 mg

Single 1.25 mg (2nd) dose of inhaled loxapine

DRUG

inhaled Loxapine 2.5 mg

Single 2.5 mg (3rd) dose of inhaled loxapine

DRUG

inhaled Loxapine 5 mg

Single 5 mg (4th) dose of inhaled loxapine

DRUG

inhaled Loxapine 10 mg

Single 10 mg (5th) dose of inhaled loxapine

DRUG

inhaled Placebo (0 mg)

Single placebo dose of inhaled loxapine

Sponsors & Collaborators

  • Alexza Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Randall Stoltz, MD · West Pharmaceutical Services, GFI Research Center, Evansville, IN 47714

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-11-30
Completion
2005-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00444028 on ClinicalTrials.gov