48 healthy adult male \& female subjects will be enrolled in this study to determine the effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible subjects will be randomized into a dosing regimen after admission.
This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Technosphere® Inhalation Powder 20mg
Tablets 400mg
Technosphere® Inhalation Powder 40mg
Charles River Clinical Services Northwest
Tacoma, Washington, United States
The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder
Time frame: 11 days
The time-matched change from baseline in QTc after therapeutic dose Technosphere® Inhalation Powder based on an individual correction (QTcI) method.
Time frame: 11 days
The maximum change in time-matched, placebo-subtracted QT interval corrected by Fridericia formula (QTcF) and Bazett formula (QTcB), respectively, for supratherapeutic dose of Technosphere® Inhalation Powder.
Time frame: 11 Days
The maximum change in time-matched, placebo-subtracted QT/QTc intervals by Fridericia formula (QTcF), and by Bazett formula (QTcB), respectively, for therapeutic dose of Technosphere® Inhalation Powder.
Time frame: 11 Days
Change in ECG morphological patterns
Time frame: 11 Days
Heart rate and RR interval.
Time frame: 11 Days
PR interval.
Time frame: 11 Days
QRS interval.
Time frame: 11 Days
Correlation between the QTcI change from baseline and plasma concentrations of FDKP.
Time frame: 11 Days
Plasma concentrations of FDKP.
Time frame: 11 Days
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Placebo cartridges