To assess the safety of Staccato Prochlorperazine on cardiac repolarization (QTc interval duration) at 2 dose levels compared to placebo in healthy volunteers.
The planned study is a single dose, double-blind, double-dummy, active and placebo controlled, randomized, 4-period cross-over study investigating investigating 2 doses levels of Staccato Prochlorperazine, a positive control with known QT/QTc prolongation (oral moxifloxacin), and placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Inhaled Staccato placebo (0 mg)
Oral placebo (identical to 400 mg moxifloxacin)
Staccato prochlorperazine 5 mg, single dose
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States
Maximum Effect of Inhaled Prochlorperazine on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
Time-matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time-matched placebo subtraction for treatment at 11 post-inhalation times.
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
QTcI Versus Prochlorperazine Concentration
QTcI @ median prochlorperazine concentration (3.75 mcg/mL) based on linear and nonlinear regression of QTcI versus time matched serum prochlorperazine concentrations
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI > 450 ms
Numbers and Percents of Subjects with QTcI exceeding 450 ms
Time frame: 24 hours
Numbers and % of Subjects With QTcI > 480 ms
Numbers and Percents of Subjects with QTcI exceeding 480 ms at any of the outcome measure time points
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI Change > 30 ms
Numbers and Percents of Subjects with QTcI increase from baseline exceeding 30 ms at any of the outcome measure time points
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
Numbers and % of Subjects With QTcI Change > 60 ms
Numbers and Percents of Subjects with QTcI increase from baseline exceeding 60 ms at any of the outcome measure time points
Time frame: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 22 hr
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Inhaled prochlorperazine 10 mg, single dose
Oral moxifloxacin 400 mg, si/ngle dose