Staccato Loxapine PK in Smokers and Nonsmokers

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Alexza Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Smoking, Cigarette

Treatments

Drug: Inhaled Loxapine 10 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00873769
27 February 2009
AMDC-004-106

Details and patient eligibility

About

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.

Full 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.

Enrollment

35 patients

Sex

All

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Healthy smokers
Experimental group
Description:
Healthy smokers, male and female
Treatment:
Drug: Inhaled Loxapine 10 mg
Healthy nonsmokers
Experimental group
Description:
Healthy nonsmokers, Healthy smokers, male and female
Treatment:
Drug: Inhaled Loxapine 10 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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