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Staccato Loxapine PK in Smokers and Nonsmokers

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00873769
First received: April 1, 2009
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

The objective of this trial is 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: Staccato Loxapine
Phase 1

Alexza Pharmaceuticals, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]

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

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: 1
Healthy smokers
Drug: Staccato Loxapine
inhalation
Active Comparator: 2
Healthy nonsmokers
Drug: Staccato Loxapine
inhalation

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Robert S. Fishman, MD, 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: June 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexza Pharmaceuticals, Inc.:
Staccato Loxapine
pharmacokinetics
smokers
non-smokers

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

ClinicalTrials.gov processed this record on November 20, 2014