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Staccato Prochlorperazine Single Dose PK Study

NCT ID: NCT00610727

Last Updated: 2025-03-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2004-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial

Study Groups

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Inhaled prochlorperazine 0.625 mg vs IV

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

Group Type EXPERIMENTAL

Prochlorperazine 0.5 mg IV over 5 sec

Intervention Type DRUG

IV Prochlorperazine for bioavailability

Inhaled prochlorperazine 0.625 mg

Intervention Type DRUG

Inhaled Staccato Prochlorperazine 0.625 mg

Prochlorperazine 10 mg IV over 5 sec

Intervention Type DRUG

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Inhaled prochlorperazine 1.25 mg

Inhaled Staccato prochlorperazine 1.25 mg

Group Type EXPERIMENTAL

Inhaled prochlorperazine 1.25 mg

Intervention Type DRUG

Inhaled Staccato Prochlorperazine 1.25 mg

Inhaled prochlorperazine 2.5 mg

Inhaled Staccato prochlorperazine 2.5 mg

Group Type EXPERIMENTAL

Inhaled prochlorperazine 2.5 mg

Intervention Type DRUG

Inhaled Staccato Prochlorperazine 2.5 mg

Inhaled prochlorperazine 5 mg

Inhaled Staccato prochlorperazine 5 mg

Group Type EXPERIMENTAL

Inhaled prochlorperazine 5 mg

Intervention Type DRUG

InhaledStaccato Prochlorperazine 5 mg

Inhaled prochlorperazine 10 mg

Inhaled Staccato prochlorperazine 10 mg

Group Type EXPERIMENTAL

Inhaled prochlorperazine 10 mg

Intervention Type DRUG

InhaledStaccato Prochlorperazine 10 mg

inhaled Placebo

inhaled Staccato Placebo (0 mg)

Group Type PLACEBO_COMPARATOR

Inhaled placebo

Intervention Type DRUG

Inhaled Staccato Placebo (0 mg)

Interventions

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Prochlorperazine 0.5 mg IV over 5 sec

IV Prochlorperazine for bioavailability

Intervention Type DRUG

Inhaled prochlorperazine 0.625 mg

Inhaled Staccato Prochlorperazine 0.625 mg

Intervention Type DRUG

Inhaled prochlorperazine 1.25 mg

Inhaled Staccato Prochlorperazine 1.25 mg

Intervention Type DRUG

Inhaled prochlorperazine 2.5 mg

Inhaled Staccato Prochlorperazine 2.5 mg

Intervention Type DRUG

Inhaled prochlorperazine 5 mg

InhaledStaccato Prochlorperazine 5 mg

Intervention Type DRUG

Inhaled prochlorperazine 10 mg

InhaledStaccato Prochlorperazine 10 mg

Intervention Type DRUG

Inhaled placebo

Inhaled Staccato Placebo (0 mg)

Intervention Type DRUG

Prochlorperazine 10 mg IV over 5 sec

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Intervention Type DRUG

Other Intervention Names

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PCZ PCZ PCZ PCZ PCZ PCZ ADASUVE placebo PCZ

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Alexza Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel A Spyker, MD

Role: STUDY_DIRECTOR

Alexza Pharmaceuticals, Inc.

Locations

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PPD Phase I Clinic

Austin, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18830225 (View on PubMed)

Other Identifiers

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AMDC-004-001

Identifier Type: -

Identifier Source: org_study_id

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