Staccato Prochlorperazine Single Dose PK Study
- Conditions
- Migraine
- Interventions
- Registration Number
- NCT00610727
- Lead Sponsor
- Alexza Pharmaceuticals, Inc.
- Brief Summary
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
- Detailed Description
The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of a single, inhaled dose of prochlorperazine (PCZ), administered as 1 or 2 puffs in healthy young volunteers.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- Subjects will be male or female subjects between the ages 18 to 45 years, inclusive in good general health as determined by medical history, physical examination, 12-lead ECG, spirometry, blood chemistry profile, hematology, urinalysis and in the opinion of the Principal Investigator.
- Subjects with a known history of allergy or intolerance to phenothiazines or related drugs or who have any disease, by history, physical examination, or laboratory abnormalities that in the investigator's opinion, would present undue risk to the subject, or may confound the interpretation of study results.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled prochlorperazine 0.625 mg vs IV Prochlorperazine 0.5 mg IV over 5 sec Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg Inhaled prochlorperazine 0.625 mg vs IV Prochlorperazine 10 mg IV over 5 sec Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg Inhaled prochlorperazine 2.5 mg Inhaled prochlorperazine 2.5 mg Inhaled Staccato prochlorperazine 2.5 mg Inhaled prochlorperazine 10 mg Inhaled prochlorperazine 10 mg Inhaled Staccato prochlorperazine 10 mg Inhaled prochlorperazine 1.25 mg Inhaled prochlorperazine 1.25 mg Inhaled Staccato prochlorperazine 1.25 mg Inhaled prochlorperazine 5 mg Inhaled prochlorperazine 5 mg Inhaled Staccato prochlorperazine 5 mg Inhaled prochlorperazine 0.625 mg vs IV Inhaled prochlorperazine 0.625 mg Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg inhaled Placebo Inhaled placebo inhaled Staccato Placebo (0 mg)
- Primary Outcome Measures
Name Time Method Time to Peak (Tmax) 24 hours Time from dose to peak prochlorperazine concentration
- Secondary Outcome Measures
Name Time Method Absolute Bioavailability of Inhaled Prochlorperazine 24 hours Absolute bioavailability of inhaled prochlorperazine via AUC infinity
Dose Proportionality of Inhaled Prochlorperazine by Power Analysis 24 hours Dose proportionality by power analysis examines the linear regression of the log-AUC versus log-Dose on a by-patient basis across all doses administered. The slope and 90% confidence interval (CI) provide a clear, quantitative (best practices) assessment of the relationship of drug delivered to dose administered. The units on such analyses are generally those of slope (rise over run), with 1.000 being "perfect". Although any positive slope might be considered clinically useful, a 90% CI within the criteria of 0.800-1.250 may be considered a delivery system which is "as good as it gets".
Trial Locations
- Locations (1)
PPD Phase I Clinic
🇺🇸Austin, Texas, United States