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Completed

NCT Number: NCT00873769

Staccato Loxapine PK in Smokers and Nonsmokers

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.

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Key information

Conditions

Smoking, Cigarette Behavior Cigarette Smoking Smoking Tobacco Smoking Tobacco Use

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit, Inc.

Evansville, Indiana, 47710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inhaled loxapine 10 mg

Drug

Staccato Loxapine 10 mg, single dose

Other names: Staccato Loxapine 10 mg

Primary outcomes

  1. Noncompartmental Pharmacokinetic parameters

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Alexza Pharmaceuticals, Inc.

Unknown

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 2, 2009
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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