NCT00610727

Staccato Prochlorperazine Single Dose PK Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Alexza Pharmaceuticals, Inc. · Unknown
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Prochlorperazine 0.5 mg IV over 5 sec	IV Prochlorperazine for bioavailability
DRUG	Inhaled prochlorperazine 0.625 mg	Inhaled Staccato Prochlorperazine 0.625 mg
DRUG	Inhaled prochlorperazine 1.25 mg	Inhaled Staccato Prochlorperazine 1.25 mg
DRUG	Inhaled prochlorperazine 2.5 mg	Inhaled Staccato Prochlorperazine 2.5 mg
DRUG	Inhaled prochlorperazine 5 mg	InhaledStaccato Prochlorperazine 5 mg
DRUG	Inhaled prochlorperazine 10 mg	InhaledStaccato Prochlorperazine 10 mg
DRUG	Inhaled placebo	Inhaled Staccato Placebo (0 mg)
DRUG	Prochlorperazine 10 mg IV over 5 sec	Prochlorperazine 10 mg IV over 5 sec for patient qualification

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-10-01
• Completion: 2004-10-01
• First posted: 2008-02-08
• Last updated: 2025-03-27
• Results posted: 2018-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study