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Completed

NCT Number: NCT00610727

Staccato Prochlorperazine Single Dose PK Study

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78704-7016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prochlorperazine 0.5 mg IV over 5 sec

Drug

IV Prochlorperazine for bioavailability

Other names: PCZ

Inhaled prochlorperazine 0.625 mg

Drug

Inhaled Staccato Prochlorperazine 0.625 mg

Other names: PCZ

Inhaled prochlorperazine 1.25 mg

Drug

Inhaled Staccato Prochlorperazine 1.25 mg

Other names: PCZ

Inhaled prochlorperazine 2.5 mg

Drug

Inhaled Staccato Prochlorperazine 2.5 mg

Other names: PCZ

Inhaled prochlorperazine 5 mg

Drug

InhaledStaccato Prochlorperazine 5 mg

Other names: PCZ

Inhaled prochlorperazine 10 mg

Drug

InhaledStaccato Prochlorperazine 10 mg

Other names: PCZ

Inhaled placebo

Drug

Inhaled Staccato Placebo (0 mg)

Other names: ADASUVE placebo

Prochlorperazine 10 mg IV over 5 sec

Drug

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Other names: PCZ

Primary outcomes

  1. Time to Peak (Tmax)

    Time frame: 24 hours

    Time from dose to peak prochlorperazine concentration

Secondary outcomes

  1. Absolute Bioavailability of Inhaled Prochlorperazine

    Time frame: 24 hours

    Absolute bioavailability of inhaled prochlorperazine via AUC infinity

  2. 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".

Sponsors and collaborators

Lead sponsor

Nova Pneuma Inc.

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Feb 8, 2008
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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