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Staccato Loxapine PK in Smokers and Nonsmokers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00873769
First received: April 1, 2009
Last updated: March 13, 2017
Last verified: June 2009
  Purpose
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 Intervention Phase
Smoking, Cigarette
Drug: Inhaled Loxapine 10 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


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

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

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

Enrollment: 35
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: 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

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.
  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873769

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

Publications:
Responsible Party: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00873769     History of Changes
Other Study ID Numbers: AMDC-004-106
27 February 2009
Study First Received: April 1, 2009
Last Updated: March 13, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

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
pharmacokinetics
smokers
non-smokers

Additional relevant MeSH terms:
Loxapine
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

ClinicalTrials.gov processed this record on April 27, 2017