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Staccato Loxapine PK in Smokers and Nonsmokers

Information source: Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Smoking, Cigarette

Intervention: Staccato Loxapine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Alexza Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
Randall R. Stoltz, MD, Principal Investigator, Affiliation: Covance Clincial Research Unit, Inc.


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.

Clinical Details

Official title: Pharmacokinetics of StaccatoŽ Loxapine for Inhalation in Smokers Compared to Nonsmokers

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Noncompartmental Pharmacokinetic parameters

Secondary outcome:

Vital signs

Treatment emergent adverse events

Sedation visual analog scale


Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Both.


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.

Locations and Contacts

Covance Clinical Research Unit, Inc., Evansville, Indiana 47710, United States
Additional Information

Starting date: April 2009
Last updated: June 18, 2009

Page last updated: August 23, 2015

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