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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled prochlorperazine 0.625 mg vs IV | Experimental | Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg |
|
| Inhaled prochlorperazine 1.25 mg | Experimental | Inhaled Staccato prochlorperazine 1.25 mg |
|
| Inhaled prochlorperazine 2.5 mg | Experimental | Inhaled Staccato prochlorperazine 2.5 mg |
|
| Inhaled prochlorperazine 5 mg | Experimental | Inhaled Staccato prochlorperazine 5 mg |
|
| Inhaled prochlorperazine 10 mg | Experimental | Inhaled Staccato prochlorperazine 10 mg |
|
| inhaled Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prochlorperazine 0.5 mg IV over 5 sec | Drug | IV Prochlorperazine for bioavailability |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Peak (Tmax) | Time from dose to peak prochlorperazine concentration | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability of Inhaled Prochlorperazine | Absolute bioavailability of inhaled prochlorperazine via AUC infinity | 24 hours |
| Dose Proportionality of Inhaled Prochlorperazine by Power Analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Spyker, MD | Alexza Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase I Clinic | Austin | Texas | 78704-7016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18830225 | Background | Avram MJ, Spyker DA, Henthorn TK, Cassella JV. The pharmacokinetics and bioavailability of prochlorperazine delivered as a thermally generated aerosol in a single breath to volunteers. Clin Pharmacol Ther. 2009 Jan;85(1):71-7. doi: 10.1038/clpt.2008.184. Epub 2008 Oct 1. |
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IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com
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| ID | Title | Description |
|---|---|---|
| FG000 | Qualification & Crossover Arm, Inhaled Prochlorperazine vs IV | Prochlorperazine 10 mg IV over 2 min qualification Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg ALL SUBJECTS RECEIVED ALL TREATMENT |
| FG001 | Inhaled Prochlorperazine 1.25 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Stage 1: open-label, single-dose stage with 3 treatment periods divided into 2 phases Stage 2: double-blind, placebo-controlled, dose-escalation treatment period
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Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial
inhaled Staccato Placebo (0 mg) |
|
| Inhaled prochlorperazine 0.625 mg | Drug | Inhaled Staccato Prochlorperazine 0.625 mg |
|
|
| Inhaled prochlorperazine 1.25 mg | Drug | Inhaled Staccato Prochlorperazine 1.25 mg |
|
|
| Inhaled prochlorperazine 2.5 mg | Drug | Inhaled Staccato Prochlorperazine 2.5 mg |
|
|
| Inhaled prochlorperazine 5 mg | Drug | InhaledStaccato Prochlorperazine 5 mg |
|
|
| Inhaled prochlorperazine 10 mg | Drug | InhaledStaccato Prochlorperazine 10 mg |
|
|
| Inhaled placebo | Drug | Inhaled Staccato Placebo (0 mg) |
|
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| Prochlorperazine 10 mg IV over 5 sec | Drug | Prochlorperazine 10 mg IV over 5 sec for patient qualification |
|
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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".
| 24 hours |
Inhaled Staccato prochlorperazine 1.25 mg Inhaled prochlorperazine 1.25 mg: Inhaled Staccato Prochlorperazine 1.25 mg |
| FG002 | Inhaled Prochlorperazine 2.5 mg | Inhaled Staccato prochlorperazine 2.5 mg Inhaled prochlorperazine 2.5 mg: Inhaled Staccato Prochlorperazine 2.5 mg |
| FG003 | Inhaled Prochlorperazine 5 mg | Inhaled Staccato prochlorperazine 5 mg Inhaled prochlorperazine 5 mg: InhaledStaccato Prochlorperazine 5 mg |
| FG004 | Inhaled Prochlorperazine 10 mg | Inhaled Staccato prochlorperazine 10 mg Inhaled prochlorperazine 10 mg: InhaledStaccato Prochlorperazine 10 mg |
| FG005 | Inhaled Placebo | inhaled Staccato Placebo (0 mg) Inhaled placebo: Inhaled Staccato Placebo (0 mg) |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Qualification & Crossover, Inhaled Prochlorperazine vs IV | Prochlorperazine 10 mg IV over 2 min qualification Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg ALL SUBJECTS RECEIVED ALL 3 TREATMENTS |
| BG001 | Inhaled Prochlorperazine 1.25 mg | Inhaled Staccato prochlorperazine 1.25 mg Inhaled prochlorperazine 1.25 mg: Inhaled Staccato Prochlorperazine 1.25 mg |
| BG002 | Inhaled Prochlorperazine 2.5 mg | Inhaled Staccato prochlorperazine 2.5 mg Inhaled prochlorperazine 2.5 mg: Inhaled Staccato Prochlorperazine 2.5 mg |
| BG003 | Inhaled Prochlorperazine 5 mg | Inhaled Staccato prochlorperazine 5 mg Inhaled prochlorperazine 5 mg: InhaledStaccato Prochlorperazine 5 mg |
| BG004 | Inhaled Prochlorperazine 10 mg | Inhaled Staccato prochlorperazine 10 mg Inhaled prochlorperazine 10 mg: InhaledStaccato Prochlorperazine 10 mg |
| BG005 | Inhaled Placebo | inhaled Staccato Placebo (0 mg) Inhaled placebo: Inhaled Staccato Placebo (0 mg) |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Peak (Tmax) | Time from dose to peak prochlorperazine concentration | Pharmacokinetic Population | Posted | Median | Inter-Quartile Range | hours | 24 hours |
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| Secondary | Absolute Bioavailability of Inhaled Prochlorperazine | Absolute bioavailability of inhaled prochlorperazine via AUC infinity | Bioavailability crossover subjects, n=8 | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Fraction absorbed | 24 hours |
|
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Dose Proportionality of Inhaled Prochlorperazine by Power Analysis | 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". | Pharmacokinetic Population, n=40 | Posted | Geometric Least Squares Mean | 90% Confidence Interval | Slope of Power Regression | 24 hours |
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Adverse events (AEs) were considered treatment related from the first exposure to study treatment until 30 days after the last treatment
Adverse events (AEs) were assessed predose and Performed throughout the 24-hour period after dosing .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Prochlorperazine 10 mg | Intravenous prochlorperazine 10 mg | 0 | 14 | 0 | 14 | 6 | 14 |
| EG001 | IV Prochlorperazine 0.5 mg | Intravenous prochlorperazine 0.5 mg | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Inhaled Prochlorperazine 0.625 | Inhaled prochlorperazine 0.625 mg | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Inhaled Prochlorperazine 1.25 mg | Inhaled Staccato prochlorperazine 1.25 mg | 0 | 8 | 0 | 8 | 5 | 8 |
| EG004 | Inhaled Prochlorperazine 2.5 mg | Inhaled Staccato prochlorperazine 2.5 mg | 0 | 8 | 0 | 8 | 3 | 8 |
| EG005 | Inhaled Prochlorperazine 5 mg | Inhaled Staccato prochlorperazine 5 mg | 0 | 8 | 0 | 8 | 0 | 8 |
| EG006 | Inhaled Prochlorperazine 10 mg | Inhaled Staccato prochlorperazine 10 mg | 0 | 8 | 0 | 8 | 4 | 8 |
| EG007 | Inhaled Placebo | inhaled Staccato Placebo (0 mg) | 0 | 8 | 0 | 8 | 0 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Sensation of pressure in face | General disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Hasegawa, VP, Device Development | Alexza Pharmaceuticals, Inc. | 650.947.7031 | dhasegawa@alexza.com |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011346 | Prochlorperazine |
| ID | Term |
|---|---|
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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