Staccato Prochlorperazine Single Dose PK Study

October 29, 2020 updated by: Alexza Pharmaceuticals, Inc.

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

The objective of this study was to evaluate the tolerability, safety, and pharmacokinetics of inhaled prochlorperazine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78704-7016
        • PPD Phase I Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inhaled prochlorperazine 0.625 mg vs IV
Prochlorperazine 0.5 mg IV over 5 sec crossover Inhaled prochlorperazine 0.625 mg
Drug: Prochlorperazine 0.5 mg IV over 5 sec
IV Prochlorperazine for bioavailability
Other Names:
  • PCZ
Drug: Inhaled prochlorperazine 0.625 mg
Inhaled Staccato Prochlorperazine 0.625 mg
Other Names:
  • PCZ
Drug: Prochlorperazine 10 mg IV over 5 sec
Prochlorperazine 10 mg IV over 5 sec for patient qualification
Other Names:
  • PCZ
Experimental: Inhaled prochlorperazine 1.25 mg
Inhaled Staccato prochlorperazine 1.25 mg
Drug: Inhaled prochlorperazine 1.25 mg
Inhaled Staccato Prochlorperazine 1.25 mg
Other Names:
  • PCZ
Experimental: Inhaled prochlorperazine 2.5 mg
Inhaled Staccato prochlorperazine 2.5 mg
Drug: Inhaled prochlorperazine 2.5 mg
Inhaled Staccato Prochlorperazine 2.5 mg
Other Names:
  • PCZ
Experimental: Inhaled prochlorperazine 5 mg
Inhaled Staccato prochlorperazine 5 mg
Drug: Inhaled prochlorperazine 5 mg
InhaledStaccato Prochlorperazine 5 mg
Other Names:
  • PCZ
Experimental: Inhaled prochlorperazine 10 mg
Inhaled Staccato prochlorperazine 10 mg
Drug: Inhaled prochlorperazine 10 mg
InhaledStaccato Prochlorperazine 10 mg
Other Names:
  • PCZ
Placebo Comparator: inhaled Placebo
inhaled Staccato Placebo (0 mg)
Drug: Inhaled placebo
Inhaled Staccato Placebo (0 mg)
Other Names:
  • ADASUVE placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Peak (Tmax)
Time Frame: 24 hours
Time from dose to peak prochlorperazine concentration
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Bioavailability of Inhaled Prochlorperazine
Time Frame: 24 hours
Absolute bioavailability of inhaled prochlorperazine via AUC infinity
24 hours
Dose Proportionality of Inhaled Prochlorperazine by Power Analysis
Time Frame: 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".
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexza Pharmaceuticals, Inc.

Collaborators

PPD

Investigators

  • Study Director: Daniel A Spyker, MD, Alexza Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

October 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

January 28, 2008

First Submitted That Met QC Criteria

January 28, 2008

First Posted (Estimate)

February 8, 2008

Study Record Updates

Last Update Posted (Actual)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDC-004-001
  • Amended September 8, 2004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Prochlorperazine 0.5 mg IV over 5 sec

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe