Staccato Prochlorperazine Thorough QT/QTc Study

This study has been completed.
Sponsor:
Information provided by:
Alexza Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00543062
First received: October 10, 2007
Last updated: November 5, 2008
Last verified: November 2008
  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:


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:

  1. Male and female subjects between the ages of 18 to 65 years, inclusive.
  2. Body mass index (BMI) ≥21 and ≤30.
  3. 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.
  4. 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.
  5. 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.
  6. 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:

  1. Subjects who regularly consume large amounts of xanthine-containing substances must be excluded.
  2. Subjects who have taken prescription or nonprescription medication within 5 days of Treatment Period 1 must be excluded.
  3. Subjects who have had an acute illness within the last 5 days of Treatment Period 1 must be excluded.
  4. Subjects who have smoked tobacco within the last year must be excluded.
  5. Subjects who have a history of HIV positivity must be excluded.
  6. Subjects who have a history of allergy or intolerance to prochlorperazine or phenothiazines must be excluded.
  7. Subjects who have a history of contraindication to anticholinergics must be excluded.
  8. Subjects who have a history of pheochromocytoma, seizure disorder, Parkinson's disease, or Restless Leg Syndrome must be excluded.
  9. Subjects who have an ECG abnormality must be excluded.
  10. 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.
  11. 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.
  12. Subjects who have a history of asthma or chronic obstructive lung disease must be excluded.
  13. Subjects who have hypotension (systolic ≤90 mmHg, diastolic ≤50 mmHg), or hypertension (systolic ≥140 mmHg, diastolic blood pressure ≥90 mmHg) must be excluded.
  14. Subjects who test positive for alcohol or have a positive urine drug screen must be excluded.
  15. Female subjects who have a positive pregnancy test at screening or during randomization visit, or are breastfeeding must be excluded.
  16. Subjects who have received an investigational drug within 30 days prior to the Screening Visit must be excluded.
  17. 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.
  18. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 September 30, 2014