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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00543062 History of Changes |
| Other Study ID Numbers: | AMDC-001-102, 20 July 2007 |
| Study First Received: | October 10, 2007 |
| Last Updated: | November 5, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |