We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Staccato Prochlorperazine Single Dose PK

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610727
First Posted: February 8, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PPD
Information provided by:
Alexza Pharmaceuticals, Inc.
  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
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
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 28, 2008
First Posted: February 8, 2008
Last Update Posted: October 12, 2017
Last Verified: September 2008

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
Prochlorperazine
Antiemetics
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