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Sponsored by: |
Alexza Pharmaceuticals, Inc. |
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Information provided by: | Alexza Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00543062 |
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 |
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1
The 4 treatments will be presented in 4 sequences
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | AMDC-001-102, 20 July 2007 |
Study First Received: | October 10, 2007 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00543062 |
Health Authority: | United States: Food and Drug Administration |
Prochlorperazine Dopamine Migraine Disorders Headache Central Nervous System Diseases |
Headache Disorders, Primary Healthy Brain Diseases Headache Disorders |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |