Back to results

Staccato Prochlorperazine Single Dose PK Study

Primary Purpose

Migraine

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Prochlorperazine 0.5 mg IV over 5 sec

Inhaled prochlorperazine 0.625 mg

Inhaled prochlorperazine 1.25 mg

Inhaled prochlorperazine 2.5 mg

Inhaled prochlorperazine 5 mg

Inhaled prochlorperazine 10 mg

Inhaled placebo

Prochlorperazine 10 mg IV over 5 sec

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Prochlorperazine aerosol

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

PPD Phase I Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled prochlorperazine 0.625 mg vs IV

Inhaled prochlorperazine 1.25 mg

Inhaled prochlorperazine 2.5 mg

Inhaled prochlorperazine 5 mg

Inhaled prochlorperazine 10 mg

inhaled Placebo

Arm Description

Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg

Inhaled Staccato prochlorperazine 1.25 mg

Inhaled Staccato prochlorperazine 2.5 mg

Inhaled Staccato prochlorperazine 5 mg

Inhaled Staccato prochlorperazine 10 mg

inhaled Staccato Placebo (0 mg)

Outcomes

Primary Outcome Measures

Time to Peak (Tmax)

Time from dose to peak prochlorperazine concentration

Secondary Outcome Measures

Absolute Bioavailability of Inhaled Prochlorperazine

Absolute bioavailability of inhaled prochlorperazine via AUC infinity

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".

Full Information

NCT ID

NCT00610727

First Posted

January 28, 2008

Last Updated

October 29, 2020

Sponsor

Alexza Pharmaceuticals, Inc.

Collaborators

PPD

1. Study Identification

Unique Protocol Identification Number

NCT00610727

Brief Title

Staccato Prochlorperazine Single Dose PK Study

Official Title

Tolerability, Safety and Pharmacokinetics of a Single Dose of Staccato™ Prochlorperazine for Inhalation in Normal, Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

October 2004 (Actual)

Study Completion Date

October 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexza Pharmaceuticals, Inc.

Collaborators

PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

Keywords

Migraine, Prochlorperazine aerosol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled prochlorperazine 0.625 mg vs IV

Arm Type

Experimental

Arm Description

Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg

Arm Title

Inhaled prochlorperazine 1.25 mg

Arm Type

Experimental

Arm Description

Inhaled Staccato prochlorperazine 1.25 mg

Arm Title

Inhaled prochlorperazine 2.5 mg

Arm Type

Experimental

Arm Description

Inhaled Staccato prochlorperazine 2.5 mg

Arm Title

Inhaled prochlorperazine 5 mg

Arm Type

Experimental

Arm Description

Inhaled Staccato prochlorperazine 5 mg

Arm Title

Inhaled prochlorperazine 10 mg

Arm Type

Experimental

Arm Description

Inhaled Staccato prochlorperazine 10 mg

Arm Title

inhaled Placebo

Arm Type

Placebo Comparator

Arm Description

inhaled Staccato Placebo (0 mg)

Intervention Type

Drug

Intervention Name(s)

Prochlorperazine 0.5 mg IV over 5 sec

Other Intervention Name(s)

PCZ

Intervention Description

IV Prochlorperazine for bioavailability

Intervention Type

Drug

Intervention Name(s)

Inhaled prochlorperazine 0.625 mg

Other Intervention Name(s)

PCZ

Intervention Description

Inhaled Staccato Prochlorperazine 0.625 mg

Intervention Type

Drug

Intervention Name(s)

Inhaled prochlorperazine 1.25 mg

Other Intervention Name(s)

PCZ

Intervention Description

Inhaled Staccato Prochlorperazine 1.25 mg

Intervention Type

Drug

Intervention Name(s)

Inhaled prochlorperazine 2.5 mg

Other Intervention Name(s)

PCZ

Intervention Description

Inhaled Staccato Prochlorperazine 2.5 mg

Intervention Type

Drug

Intervention Name(s)

Inhaled prochlorperazine 5 mg

Other Intervention Name(s)

PCZ

Intervention Description

InhaledStaccato Prochlorperazine 5 mg

Intervention Type

Drug

Intervention Name(s)

Inhaled prochlorperazine 10 mg

Other Intervention Name(s)

PCZ

Intervention Description

InhaledStaccato Prochlorperazine 10 mg

Intervention Type

Drug

Intervention Name(s)

Inhaled placebo

Other Intervention Name(s)

ADASUVE placebo

Intervention Description

Inhaled Staccato Placebo (0 mg)

Intervention Type

Drug

Intervention Name(s)

Prochlorperazine 10 mg IV over 5 sec

Other Intervention Name(s)

PCZ

Intervention Description

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Primary Outcome Measure Information:

Title

Time to Peak (Tmax)

Description

Time from dose to peak prochlorperazine concentration

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Absolute Bioavailability of Inhaled Prochlorperazine

Description

Absolute bioavailability of inhaled prochlorperazine via AUC infinity

Time Frame

24 hours

Title

Dose Proportionality of Inhaled Prochlorperazine by Power Analysis

Description

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel A Spyker, MD

Organizational Affiliation

Alexza Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

PPD Phase I Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78704-7016

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD submitted to regulatory authorities. Others may contact Alexza Pharmaceuticals, Inc. Please send your request to ClinicalTrialsInfo@alexza.com

Citations:

PubMed Identifier

18830225

Citation

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.

Results Reference

background

Learn more about this trial

Staccato Prochlorperazine Single Dose PK Study

We'll reach out to this number within 24 hrs