Staccato Prochlorperazine Single Dose PK Study

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610727
• Other study ID #: AMDC-004-001
• Secondary ID: Amended Septembe
• Status: Completed
• Phase: Phase 1
• Start date: August 2004
• Est. completion date: October 2004

Study information

• Verified date: September 2008
• Source: Alexza Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Prochlorperazine 0.5 mg IV over 5 sec
IV Prochlorperazine for bioavailability
• Inhaled prochlorperazine 0.625 mg
Inhaled Staccato Prochlorperazine 0.625 mg
• Inhaled prochlorperazine 1.25 mg
Inhaled Staccato Prochlorperazine 1.25 mg
• Inhaled prochlorperazine 2.5 mg
Inhaled Staccato Prochlorperazine 2.5 mg
• Inhaled prochlorperazine 5 mg
InhaledStaccato Prochlorperazine 5 mg
• Inhaled prochlorperazine 10 mg
InhaledStaccato Prochlorperazine 10 mg
• Inhaled placebo
Inhaled Staccato Placebo (0 mg)
• Prochlorperazine 10 mg IV over 5 sec
Prochlorperazine 10 mg IV over 5 sec for patient qualification

Locations

Country	Name	City	State
United States	PPD Phase I Clinic	Austin	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Alexza Pharmaceuticals, Inc.	PPD

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Peak (Tmax)	Time from dose to peak prochlorperazine concentration	24 hours
Secondary	Absolute Bioavailability of Inhaled Prochlorperazine	Absolute bioavailability of inhaled prochlorperazine via AUC infinity	24 hours
Secondary	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".	24 hours