Staccato Zaleplon Single Dose Pharmacokinetics

NCT00620620 | Completed Phase 1 FDA Drug

• 2 other identifiers: AMDC-007-10117 December 2007
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Healthy adult volunteers

Outcome Measures

Primary Outcomes (1)

• Examine the tolerability and safety of Staccato Zaleplon in a healthy volunteer population;

  Single dose

Secondary Outcomes (1)

• Establish the plasma level-time profile (pharmacokinetics) of zaleplon in the target therapeutic range following single Staccato Zaleplon doses

  single dose

Study Arms (5)

Inhaled Placebo

PLACEBO COMPARATOR

Staccato Placebo

Drug: Inhaled placebo

Inhaled Zaleplon 0.5 mg

EXPERIMENTAL

Staccato Zaleplon 0.5 mg

Drug: Inhaled Zaleplon 0.5 mg

Inhaled Zaleplon 1 mg

EXPERIMENTAL

Staccato Zaleplon 1 mg

Drug: Inhaled Zaleplon 1 mg

Inhaled Zaleplon 2 mg

EXPERIMENTAL

Staccato Zaleplon 2 mg

Drug: Inhaled Zaleplon 2 mg

Inhaled Zaleplon 4 mg

EXPERIMENTAL

Staccato Zaleplon 4 mg

Drug: Inhaled Zaleplon 4 mg

Interventions

Inhaled placebo DRUG

Inhaled Staccato Placebo

Also known as: Staccato Placebo

Inhaled Placebo

Inhaled Zaleplon 0.5 mg DRUG

Inhaled Staccato Zaleplon 0.5 mg

Also known as: Staccato Zaleplon 0.5 mg

Inhaled Zaleplon 0.5 mg

Inhaled Zaleplon 1 mg DRUG

Inhaled Staccato Zaleplon 1 mg

Also known as: Staccato Zaleplon 1 mg

Inhaled Zaleplon 1 mg

Inhaled Zaleplon 2 mg DRUG

Inhaled Staccato Zaleplon 2 mg

Also known as: Staccato Zaleplon 2 mg

Inhaled Zaleplon 2 mg

Inhaled Zaleplon 4 mg DRUG

Inhaled Staccato Zaleplon 4 mg

Also known as: Staccato Zaleplon 4 mg

Inhaled Zaleplon 4 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexza Pharmaceuticals, Inc.: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47714, United States

Location

Related Publications (1)

• Avram MJ, Spyker DA, Kehne JH, Cassella JV. The pharmacokinetics and pharmacodynamics of zaleplon delivered as a thermally generated aerosol in a single breath to volunteers. J Clin Pharmacol. 2013 Feb;53(2):140-50. doi: 10.1177/0091270012436886.

  PMID: 23436259 BACKGROUND

Study Officials

• Daniel A Spyker, MD

  Alexza Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: March 14, 2017

Record last verified: 2013-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)