Staccato Loxapine Thorough QT/QTc

This study has been completed.
Information provided by:
Alexza Pharmaceuticals, Inc. Identifier:
First received: April 1, 2009
Last updated: June 18, 2009
Last verified: June 2009
The purpose of the present Phase 1 study is to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.

Condition Intervention Phase
Drug: 1 (Staccato Loxapine)
Drug: 2 (Moxifloxacin)
Drug: 3 (Placebo)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Time-matched average differences in QTc between active drug and placebo [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Staccato Loxapine
Drug: 1 (Staccato Loxapine)
Staccato Loxapine
Active Comparator: 2
Oral moxifloxacin
Drug: 2 (Moxifloxacin)
Oral moxifloxacin
Placebo Comparator: 3
Drug: 3 (Placebo)


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.

Exclusion Criteria:

  • Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
  • Subjects who have had an acute illness within the last 5 days of treatment,
  • Subjects who are smokers, OR
  • Subjects who have an ECG abnormality at baseline.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00874237

United States, Indiana
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Principal Investigator: Randall R. Stoltz, MD Covance
  More Information

Responsible Party: Robert Fishman, MD, Alexza Pharmaceuticals, Inc. Identifier: NCT00874237     History of Changes
Other Study ID Numbers: AMDC-004-107  February 26, 2009 
Study First Received: April 1, 2009
Last Updated: June 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato loxapine
healthy volunteers

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Tranquilizing Agents processed this record on May 26, 2016