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Staccato Loxapine Thorough QT/QTc

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00874237
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : June 22, 2009
Information provided by:
Alexza Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: 1 (Staccato Loxapine) Drug: 2 (Moxifloxacin) Drug: 3 (Placebo) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Thorough QT/QTc Study of Staccato® Loxapine for Inhalation in Healthy Volunteers
Study Start Date : April 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Time-matched average differences in QTc between active drug and placebo [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. QTc versus loxapine concentration relationship following treatment with Staccato Loxapine in healthy volunteers. [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00874237

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

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Responsible Party: Robert Fishman, MD, Alexza Pharmaceuticals, Inc. Identifier: NCT00874237     History of Changes
Other Study ID Numbers: AMDC-004-107
February 26, 2009
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009
Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato loxapine
healthy volunteers
Additional relevant MeSH terms:
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Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents