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| Sponsor: | Alexza Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Alexza Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00543062 |
Purpose
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine |
Drug: Prochlorperazine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
| Official Title: | Thorough QT/QTc Study of Staccato® Prochlorperazine for Inhalation in Healthy Volunteers |
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
The 4 treatments will be presented in 4 sequences
|
Drug: Prochlorperazine |
The planned study is a single dose, double-blind, double-dummy, active and placebo controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral moxifloxacin), and placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Covance Clinical Research Unit Inc. | |
| Evansville, Indiana, United States, 47714 | |
| Principal Investigator: | Randall R Stoltz, MD | Covance GFI Research, Evansville, IN 47714 |
More Information
| Study ID Numbers: | AMDC-001-102, 20 July 2007 |
| Study First Received: | October 10, 2007 |
| Last Updated: | November 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00543062 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Prochlorperazine Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Central Nervous System Diseases Antiemetics Dopamine Antagonists |
Headache Disorders, Primary Antipsychotic Agents Brain Diseases Pharmacologic Actions Headache Disorders Migraine Disorders Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |