Staccato Prochlorperazine Single Dose PK Study

Alexza Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Migraine

Treatments: Drug: Inhaled prochlorperazine 5 mg; Drug: Inhaled prochlorperazine 1.25 mg; Drug: Prochlorperazine 10 mg IV over 5 sec; Drug: Inhaled prochlorperazine 10 mg; Drug: Inhaled placebo; Drug: Prochlorperazine 0.5 mg IV over 5 sec; Drug: Inhaled prochlorperazine 0.625 mg; Drug: Inhaled prochlorperazine 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00610727

AMDC-004-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 6 patient groups, including a placebo group

Inhaled prochlorperazine 0.625 mg vs IV

Experimental group

Description:

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

Treatment:

Drug: Inhaled prochlorperazine 0.625 mg

Drug: Prochlorperazine 0.5 mg IV over 5 sec

Drug: Prochlorperazine 10 mg IV over 5 sec

Inhaled prochlorperazine 1.25 mg

Experimental group

Description:

Inhaled Staccato prochlorperazine 1.25 mg

Treatment:

Drug: Inhaled prochlorperazine 1.25 mg

Inhaled prochlorperazine 2.5 mg

Experimental group

Description:

Inhaled Staccato prochlorperazine 2.5 mg

Treatment:

Drug: Inhaled prochlorperazine 2.5 mg

Inhaled prochlorperazine 5 mg

Experimental group

Description:

Inhaled Staccato prochlorperazine 5 mg

Treatment:

Drug: Inhaled prochlorperazine 5 mg

Inhaled prochlorperazine 10 mg

Experimental group

Description:

Inhaled Staccato prochlorperazine 10 mg

Treatment:

Drug: Inhaled prochlorperazine 10 mg

inhaled Placebo

Placebo Comparator group

Description:

inhaled Staccato Placebo (0 mg)

Treatment:

Drug: Inhaled placebo