Staccato Loxapine PK in Smokers and Nonsmokers

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: NCT00873769
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : March 15, 2017
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.

Brief Summary:
The objective of this trial was to assess the pharmacokinetics of a single dose of 10 mg Staccato Loxapine administered to smokers compared to nonsmokers.

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Drug: Inhaled Loxapine 10 mg Phase 1

Detailed Description:
Pharmacokinetics and sedation pharmacodynamics were studied using a visual analog scale were studied in male and female adult subjects (nonsmokers and smokers) following a single dose of 10 mg of inhaled loxapine. Blood samples were drawn at predose, 30 seconds, 1, 2, 3, 10, 30, and 60 minutes, and 2, 6, 12, and 24 hours after dosing. Loxapine and 8-OH-loxapine were analyzed using reverse-phase liquid chromatography coupled with a tandem mass spectrometer.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Single-center, single-dose, single-treatment, open label study
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers
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

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Healthy smokers
Healthy smokers, male and female
Drug: Inhaled Loxapine 10 mg
Staccato Loxapine 10 mg, single dose
Other Name: Staccato Loxapine 10 mg
Experimental: Healthy nonsmokers
Healthy nonsmokers, Healthy smokers, male and female
Drug: Inhaled Loxapine 10 mg
Staccato Loxapine 10 mg, single dose
Other Name: Staccato Loxapine 10 mg

Primary Outcome Measures :
  1. Noncompartmental Pharmacokinetic parameters [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Vital signs [ Time Frame: 24 hours ]
  2. Treatment emergent adverse events [ Time Frame: 24 hours ]
  3. Sedation visual analog scale [ Time Frame: 24 hours ]

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Normal spirometry at screening and in good general health as determined by a complete medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, and urinalysis,
  • Smokers must have a history of smoking > 15 cigarettes/day currently and for at least the last 2 years,
  • Nonsmokers must have never smoked > 5 cigarettes/day and not smoking at all for at least the last 2 years.

Exclusion Criteria:

  • Any acute illness in the 5 days,
  • Use of a bronchodilator for the treatment of wheezing within 12 months, OR
  • Any other disease or condition, by history, physical examination, or laboratory abnormalities that would present undue risk to the subject, or may confound the interpretation of study results.

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): NCT00873769

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 Clincial Research Unit, Inc.

Responsible Party: Alexza Pharmaceuticals, Inc. Identifier: NCT00873769     History of Changes
Other Study ID Numbers: AMDC-004-106
27 February 2009
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: June 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato Loxapine

Additional relevant MeSH terms:
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action