Staccato Prochlorperazine Single Dose PK
This study has been completed.
Sponsor:
Alexza Pharmaceuticals, Inc.
Collaborator:
Pharmaceutical Product Development (PPD) LP
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00610727
First received: January 28, 2008
Last updated: April 27, 2009
Last verified: September 2008
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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:
Genetics Home Reference related topics:
familial hemiplegic migraine
MedlinePlus related topics:
Migraine
Drug Information available for:
Prochlorperazine
Prochlorperazine maleate
Prochlorperazine edisylate
U.S. FDA Resources
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
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.
Pharmaceutical Product Development (PPD) LP
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:
|
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 Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013