| October 10, 2007 |
| November 5, 2008 |
| October 2007 |
| December 2007 (final data collection date for primary outcome measure) |
| Time-matched differences in changes from baseline for each treatment vs. placebo QTc [ Time Frame: At each post-treatment time point ] |
| Same as current |
| Complete list of historical versions of study NCT00543062 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| Staccato Prochlorperazine Thorough QT/QTc Study |
| Thorough QT/QTc Study of Staccato® Prochlorperazine for Inhalation in Healthy Volunteers |
To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers. |
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. |
| Phase I |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
| Migraine |
| Drug: Prochlorperazine |
| Other: The 4 treatments will be presented in 4 sequences |
| |
| |
| Completed |
| 48 |
| December 2007 |
| December 2007 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years to 65 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00543062 |
|
| AMDC-001-102, 20 July 2007 |
| Alexza Pharmaceuticals, Inc. |
|
| Principal Investigator: |
Randall R Stoltz, MD |
Covance GFI Research, Evansville, IN 47714 |
|
|
| Alexza Pharmaceuticals, Inc. |
| November 2008 |