Staccato Prochlorperazine Single Dose PK Study

Nova Pneuma Inc.54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Migraine

Interventions

Prochlorperazine 0.5 mg IV over 5 secDRUG

IV Prochlorperazine for bioavailability

Inhaled prochlorperazine 0.625 mgDRUG

Inhaled Staccato Prochlorperazine 0.625 mg

Inhaled prochlorperazine 1.25 mgDRUG

Inhaled Staccato Prochlorperazine 1.25 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PPD Phase I Clinic

Austin, Texas, United States

Outcomes

Primary Outcomes

Time to Peak (Tmax)

Time from dose to peak prochlorperazine concentration

Time frame: 24 hours

Secondary Outcomes

Absolute Bioavailability of Inhaled Prochlorperazine

Absolute bioavailability of inhaled prochlorperazine via AUC infinity

Time frame: 24 hours

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".

Time frame: 24 hours

Data from ClinicalTrials.gov

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