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Staccato Prochlorperazine Single Dose PK

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.
ClinicalTrials.gov Identifier: NCT00610727
Recruitment Status : Completed
First Posted : February 8, 2008
Last Update Posted : April 29, 2009
Sponsor:
Collaborator:
PPD
Information provided by:
Alexza Pharmaceuticals, Inc.

Brief Summary:
To evaluate the tolerability and safety of inhaled prochlorperazine To evaluate the pharmacokinetics of inhaled prochlorperazine

Condition or disease Intervention/treatment Phase
Migraine Drug: Prochlorperazine Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
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
Study Start Date : August 2004
Primary Completion Date : October 2004
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arm Intervention/treatment
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




Information from the National Library of Medicine

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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.

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.

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 Posted: February 8, 2008    Key Record Dates
Last Update Posted: April 29, 2009
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