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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

January 28, 2008
April 27, 2009
August 2004
October 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00610727 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Staccato Prochlorperazine Single Dose PK
Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers

To evaluate the tolerability and safety of inhaled prochlorperazine To evaluate the pharmacokinetics of inhaled prochlorperazine

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Migraine
  • Drug: Prochlorperazine
    10 mg IV over 2 min
  • Drug: Prochlorperazine
    0.5 mg IV over 5 sec
  • Drug: Prochlorperazine
    Staccato Prochlorperazine 0.625 mg
  • Drug: Prochlorperazine
    Staccato Prochlorperazine 1.25 mg
  • Drug: Prochlorperazine
    Staccato Prochlorperazine 2.5 mg
  • Drug: Prochlorperazine
    Staccato Prochlorperazine 5 mg
  • Drug: Prochlorperazine
    Staccato Prochlorperazine 10 mg
  • Drug: Placebo
    Staccato Placebo
  • 1
    Crossover for absolute bioavailability
    Interventions:
    • Drug: Prochlorperazine
    • Drug: Prochlorperazine
    • Drug: Prochlorperazine
  • Experimental: 2
    Dose 2 vs. placebo
    Interventions:
    • Drug: Prochlorperazine
    • Drug: Placebo
  • Experimental: 3
    Dose 3 vs. Placebo
    Interventions:
    • Drug: Prochlorperazine
    • Drug: Placebo
  • Experimental: 4
    Dose 4 vs. Placebo
    Interventions:
    • Drug: Prochlorperazine
    • Drug: Placebo
  • Experimental: 5
    Dose 5 vs. Placebo
    Interventions:
    • Drug: Prochlorperazine
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2004
October 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610727
AMDC 04-001, Amended September 8, 2004
No
Daniel A. Spyker, MD; Sr Director, Drug Safety & Pharmacovigilance, Alexza Pharmaceuticals, Inc
Alexza Pharmaceuticals, Inc.
PPD
Study Director: Daniel A Spyker, MD Alexza Pharmaceuticals, Inc.
Alexza Pharmaceuticals, Inc.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP