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Staccato Prochlorperazine Single Dose PK

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00610727
First received: January 28, 2008
Last updated: April 27, 2009
Last verified: September 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
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
1
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00610727

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

No publications provided

Responsible Party: Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Prochlorperazine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014