Staccato Prochlorperazine Thorough QT/QTc Study
This study has been completed.
Sponsor:
Alexza Pharmaceuticals, Inc.
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00543062
First received: October 10, 2007
Last updated: November 5, 2008
Last verified: November 2008
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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 |
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.:
Primary Outcome Measures:
- Time-matched differences in changes from baseline for each treatment vs. placebo QTc [ Time Frame: At each post-treatment time point ]
Secondary Outcome Measures:
- Categorical analysis of incidence of numbers and percents of subjects with absolute values and changes from baseline [ Time Frame: At each post-treatment time point ]
| 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 |
Detailed Description:
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 |
Criteria
Inclusion Criteria:
- Male and female subjects between the ages of 18 to 65 years, inclusive.
- Body mass index (BMI) ≥21 and ≤30.
- Subjects who are willing and able to comply with the study schedule and requirements, and stay at the CRU for a 3-day period and 3 consecutive 2-day periods.
- Subjects who speak, read, and understand English and are willing and able to provide written informed consent on an IRB approved form prior to the initiation of any study procedures.
- Subjects who are in good general health prior to study participation as determined by a detailed medical history, physical examination, 12-lead ECG, blood chemistry profile, hematology, urinalysis, and in the opinion of the Principal Investigator.
- Female participants (if of child-bearing potential and sexually active) and male participants (if sexually active with a partner of child-bearing potential) who agree to use a medically acceptable and effective birth control method throughout the study and for one week following the end of the study.
Exclusion Criteria:
- Subjects who regularly consume large amounts of xanthine-containing substances must be excluded.
- Subjects who have taken prescription or nonprescription medication within 5 days of Treatment Period 1 must be excluded.
- Subjects who have had an acute illness within the last 5 days of Treatment Period 1 must be excluded.
- Subjects who have smoked tobacco within the last year must be excluded.
- Subjects who have a history of HIV positivity must be excluded.
- Subjects who have a history of allergy or intolerance to prochlorperazine or phenothiazines must be excluded.
- Subjects who have a history of contraindication to anticholinergics must be excluded.
- Subjects who have a history of pheochromocytoma, seizure disorder, Parkinson's disease, or Restless Leg Syndrome must be excluded.
- Subjects who have an ECG abnormality must be excluded.
- Subjects who have a history within the past 2 years of drug or alcohol dependence or abuse as defined by DSM-4 must be excluded.
- Subjects who have a history of syncope, unstable angina, myocardial infarction (within 6 months), congestive heart failure, transient ischemic attack, or pheochromocytoma must be excluded.
- Subjects who have a history of asthma or chronic obstructive lung disease must be excluded.
- Subjects who have hypotension (systolic ≤90 mmHg, diastolic ≤50 mmHg), or hypertension (systolic ≥140 mmHg, diastolic blood pressure ≥90 mmHg) must be excluded.
- Subjects who test positive for alcohol or have a positive urine drug screen must be excluded.
- Female subjects who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
- Subjects who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
- Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving prochlorperazine, or unable to use the inhalation device, must be excluded.
- Subjects who have any other disease(s), by history, physical examination, or laboratory abnormalities (ALT or AST > 2-fold the upper limit of normal, bilirubin > 1.5 mg/dL, or creatinine > 1.8 mg/dL) or that in the investigator's opinion present undue risk to the subject or may confound the interpretation of study results must be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543062
Locations
| United States, Indiana | |
| Covance Clinical Research Unit Inc. | |
| Evansville, Indiana, United States, 47714 | |
Sponsors and Collaborators
Alexza Pharmaceuticals, Inc.
Investigators
| Principal Investigator: | Randall R Stoltz, MD | Covance GFI Research, Evansville, IN 47714 |
More Information
No publications provided
| 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 |
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