Staccato Loxapine PK in Smokers and Nonsmokers

Smoking, Cigarette Clinical Trial

Official title:

Pharmacokinetics of Staccato® Loxapine for Inhalation in Smokers Compared to Nonsmokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873769
• Other study ID #: AMDC-004-106
• Secondary ID: 27 February 2009
• Status: Completed
• Phase: Phase 1
• First received: April 1, 2009
• Last updated: March 13, 2017
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking, Cigarette

Intervention

Drug:
• Inhaled Loxapine 10 mg
Staccato Loxapine 10 mg, single dose

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc.	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Takahashi LH, Huie K, Spyker DA, Fishman RS, Cassella JV. Effect of smoking on the pharmacokinetics of inhaled loxapine. Ther Drug Monit. 2014 Oct;36(5):618-23. doi: 10.1097/FTD.0000000000000048. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Noncompartmental Pharmacokinetic parameters		24 hours
Secondary	Vital signs		24 hours
Secondary	Treatment emergent adverse events		24 hours
Secondary	Sedation visual analog scale		24 hours