Staccato Zaleplon Single Dose Pharmacokinetics

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Inhaled Zaleplon 4 mg; Drug: Inhaled placebo; Drug: Inhaled Zaleplon 1 mg; Drug: Inhaled Zaleplon 2 mg; Drug: Inhaled Zaleplon 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620620

AMDC-007-101

17 December 2007

Details and patient eligibility

About

The purpose of the study is to determine the safety, tolerability and pharmacokinetics of zaleplon delivered by the Staccato thermal aerosol system in healthy volunteers

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female subjects between the ages of 18 to 55 years, inclusive who are in good general health

Exclusion criteria

• Subjects with a history of allergy or intolerance to zaleplon. Subjects who have any other disease or condition, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups, including a placebo group

Inhaled Placebo

Placebo Comparator group

Description:

Staccato Placebo

Treatment:

Drug: Inhaled placebo

Inhaled Zaleplon 0.5 mg

Experimental group

Description:

Staccato Zaleplon 0.5 mg

Treatment:

Drug: Inhaled Zaleplon 0.5 mg

Inhaled Zaleplon 1 mg

Experimental group

Description:

Staccato Zaleplon 1 mg

Treatment:

Drug: Inhaled Zaleplon 1 mg

Inhaled Zaleplon 2 mg

Experimental group

Description:

Staccato Zaleplon 2 mg

Treatment:

Drug: Inhaled Zaleplon 2 mg

Inhaled Zaleplon 4 mg

Experimental group

Description:

Staccato Zaleplon 4 mg

Treatment:

Drug: Inhaled Zaleplon 4 mg