Healthy
Conditions
Keywords
Healthy adult volunteers
Brief summary
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
Interventions
DRUGInhaled placebo
Inhaled Staccato Placebo
DRUGInhaled Zaleplon 0.5 mg
Inhaled Staccato Zaleplon 0.5 mg
DRUGInhaled Zaleplon 1 mg
Inhaled Staccato Zaleplon 1 mg
DRUGInhaled Zaleplon 2 mg
Inhaled Staccato Zaleplon 2 mg
DRUGInhaled Zaleplon 4 mg
Inhaled Staccato Zaleplon 4 mg
Sponsors
Alexza Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population; | Single dose |
Secondary
| Measure | Time frame |
|---|---|
| Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses | single dose |
Countries
United States
Outcome results
None listed