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Staccato Prochlorperazine Single Dose PK

This study has been completed.
Information provided by:
Alexza Pharmaceuticals, Inc. Identifier:
First received: January 28, 2008
Last updated: April 27, 2009
Last verified: September 2008
To evaluate the tolerability and safety of inhaled prochlorperazine To evaluate the pharmacokinetics of inhaled prochlorperazine

Condition Intervention Phase
Migraine Drug: Prochlorperazine Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers

Resource links provided by NLM:

Further study details as provided by Alexza Pharmaceuticals, Inc.:

Enrollment: 32
Study Start Date: August 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Crossover for absolute bioavailability
Drug: Prochlorperazine
10 mg IV over 2 min
Drug: Prochlorperazine
0.5 mg IV over 5 sec
Drug: Prochlorperazine
Staccato Prochlorperazine 0.625 mg
Experimental: 2
Dose 2 vs. placebo
Drug: Prochlorperazine
Staccato Prochlorperazine 1.25 mg
Drug: Placebo
Staccato Placebo
Experimental: 3
Dose 3 vs. Placebo
Drug: Prochlorperazine
Staccato Prochlorperazine 2.5 mg
Drug: Placebo
Staccato Placebo
Experimental: 4
Dose 4 vs. Placebo
Drug: Prochlorperazine
Staccato Prochlorperazine 5 mg
Drug: Placebo
Staccato Placebo
Experimental: 5
Dose 5 vs. Placebo
Drug: Prochlorperazine
Staccato Prochlorperazine 10 mg
Drug: Placebo
Staccato Placebo


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.

Exclusion Criteria:

  • Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00610727

United States, Texas
PPD Phase I Clinic
Austin, Texas, United States, 78704-7016
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Study Director: Daniel A Spyker, MD Alexza Pharmaceuticals, Inc.
  More Information

Responsible Party: Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc Identifier: NCT00610727     History of Changes
Other Study ID Numbers: AMDC 04-001
Amended September 8, 2004
Study First Received: January 28, 2008
Last Updated: April 27, 2009

Keywords provided by Alexza Pharmaceuticals, Inc.:
Migraine, Prochlorperazine aerosol

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017