Trial | NCT00610727

Trial | NCT00610727 Report issue

Title

Staccato Prochlorperazine Single Dose PK Study

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

Phase
Phase 1

Lead Sponsor
Alexza Pharmaceuticals, Inc.

Study Type
Interventional

Status
Completed Results Posted

Indication/Condition
Migraine

Intervention/Treatment
prochlorperazine ...
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

Study Participants
54

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

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 Started

Aug 31

2004

Primary Completion

Oct 31

2004

Study Completion

Oct 31

2004

Results Posted

Nov 05

2018

Last Update

Oct 30

2020

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 Inhaled prochlorperazine 1.25 mg

Inhaled Staccato Prochlorperazine 1.25 mg

Other names: PCZ

Drug Inhaled prochlorperazine 2.5 mg

Inhaled Staccato Prochlorperazine 2.5 mg

Other names: PCZ

Drug Inhaled prochlorperazine 5 mg

InhaledStaccato Prochlorperazine 5 mg

Other names: PCZ

Drug Inhaled prochlorperazine 10 mg

InhaledStaccato Prochlorperazine 10 mg

Other names: PCZ

Drug Inhaled placebo

Inhaled Staccato Placebo (0 mg)

Other names: ADASUVE placebo

Drug Prochlorperazine 10 mg IV over 5 sec

Prochlorperazine 10 mg IV over 5 sec for patient qualification

Other names: PCZ

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

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.

Summary

IV Prochlorperazine 10 mg

IV Prochlorperazine 0.5 mg

Inhaled Prochlorperazine 0.625

Inhaled Prochlorperazine 1.25 mg

Inhaled Prochlorperazine 2.5 mg

Inhaled Prochlorperazine 5 mg

Inhaled Prochlorperazine 10 mg

Inhaled Placebo

All Events

Event Type	Organ System	Event Term	IV Prochlorperazine 10 mg	IV Prochlorperazine 0.5 mg	Inhaled Prochlorperazine 0.625	Inhaled Prochlorperazine 1.25 mg	Inhaled Prochlorperazine 2.5 mg	Inhaled Prochlorperazine 5 mg	Inhaled Prochlorperazine 10 mg	Inhaled Placebo

Time to Peak (Tmax)

Time from dose to peak prochlorperazine concentration

0.5 mg 5 Sec IV

0.042

hours (Median)

Inter-Quartile Range: 0.025 to 0.067

0.625 mg Inhaled Prochlorperazine

0.033

hours (Median)

Inter-Quartile Range: 0.025 to 0.042

1.25 mg Inhaled

0.025

hours (Median)

Inter-Quartile Range: 0.013 to 0.082

2.5 mg Inhaled

0.033

hours (Median)

Inter-Quartile Range: 0.017 to 0.033

5 mg Inhaled

0.04

hours (Median)

Inter-Quartile Range: 0.017 to 0.115

10 mg Inhaled

0.033

hours (Median)

Inter-Quartile Range: 0.013 to 0.108

Absolute Bioavailability of Inhaled Prochlorperazine

Absolute bioavailability of inhaled prochlorperazine via AUC infinity

Bioavailability Crossover Arm

0.98

Fraction absorbed (Geometric Least Squares Mean)

90% Confidence Interval: 0.73 to 1.34

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".