Staccato Prochlorperazine Single Dose PK Study

NCT00610727 | Completed Phase 1 Results FDA Drug

• 1 other identifier: AMDC-004-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Keywords

Migraine, Prochlorperazine aerosol

Outcome Measures

Primary Outcomes (1)

• Time to Peak (Tmax)

  Time from dose to peak prochlorperazine concentration

  24 hours

Secondary Outcomes (2)

• Absolute Bioavailability of Inhaled Prochlorperazine

  24 hours

• Dose Proportionality of Inhaled Prochlorperazine by Power Analysis

  24 hours

Study Arms (6)

Inhaled prochlorperazine 0.625 mg vs IV

EXPERIMENTAL

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

Drug: Prochlorperazine 0.5 mg IV over 5 sec; Drug: Inhaled prochlorperazine 0.625 mg; Drug: Prochlorperazine 10 mg IV over 5 sec

Inhaled prochlorperazine 1.25 mg

EXPERIMENTAL

Inhaled Staccato prochlorperazine 1.25 mg

Drug: Inhaled prochlorperazine 1.25 mg

Inhaled prochlorperazine 2.5 mg

EXPERIMENTAL

Inhaled Staccato prochlorperazine 2.5 mg

Drug: Inhaled prochlorperazine 2.5 mg

Inhaled prochlorperazine 5 mg

EXPERIMENTAL

Inhaled Staccato prochlorperazine 5 mg

Drug: Inhaled prochlorperazine 5 mg

Inhaled prochlorperazine 10 mg

EXPERIMENTAL

Inhaled Staccato prochlorperazine 10 mg

Drug: Inhaled prochlorperazine 10 mg

inhaled Placebo

PLACEBO COMPARATOR

inhaled Staccato Placebo (0 mg)

Drug: Inhaled placebo

Interventions

Prochlorperazine 0.5 mg IV over 5 sec DRUG

IV Prochlorperazine for bioavailability

Also known as: PCZ

Inhaled prochlorperazine 0.625 mg vs IV

Inhaled prochlorperazine 0.625 mg DRUG

Inhaled Staccato Prochlorperazine 0.625 mg

Also known as: PCZ

Inhaled prochlorperazine 0.625 mg vs IV

Inhaled prochlorperazine 1.25 mg DRUG

Inhaled Staccato Prochlorperazine 1.25 mg

Also known as: PCZ

Inhaled prochlorperazine 1.25 mg

Inhaled prochlorperazine 2.5 mg DRUG

Inhaled Staccato Prochlorperazine 2.5 mg

Also known as: PCZ

Inhaled prochlorperazine 2.5 mg

Inhaled prochlorperazine 5 mg DRUG

InhaledStaccato Prochlorperazine 5 mg

Also known as: PCZ

Inhaled prochlorperazine 5 mg

Inhaled prochlorperazine 10 mg DRUG

InhaledStaccato Prochlorperazine 10 mg

Also known as: PCZ

Inhaled prochlorperazine 10 mg

Inhaled placebo DRUG

Inhaled Staccato Placebo (0 mg)

Also known as: ADASUVE placebo

inhaled Placebo

Prochlorperazine 10 mg IV over 5 sec DRUG

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Also known as: PCZ

Inhaled prochlorperazine 0.625 mg vs IV

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PPD Development, LP: collaborator
• Nova Pneuma Inc.: lead

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78704-7016, United States

Location

Related Publications (1)

• 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.

  PMID: 18830225 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Prochlorperazine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dave Hasegawa, VP, Device Development
• Organization: Alexza Pharmaceuticals, Inc.

dhasegawa@alexza.com

650.947.7031

Study Officials

• Daniel A Spyker, MD

  Alexza Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stage 2 was a double-blind, placebo-controlled, 4 step dose-escalation trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 28, 2008
• First Posted: February 8, 2008
• Study Start: August 1, 2004
• Primary Completion: October 1, 2004
• Study Completion: October 1, 2004
• Last Updated: April 22, 2026
• Results First Posted: November 5, 2018

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)