The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.
The secondary purposes of this study are to 1) determine if there is a relationship between the duration of the QTc intervals and the plasma concentrations of carmoterol; 2) expand the available information on plasma pharmacokinetics and urine excretion for inhaled carmoterol at the proposed therapeutic and supra-therapeutic doses; and 3) generate additional safety information.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
47
Inhaled solution, single therapeutic dose
Inhaled solution, single supratherapeutic dose
Inhaled solution, single dose of placebo
PRACS Institute, Ltd.
Fargo, North Dakota, United States
QTci
Time frame: ECGs taken every treatment period on day -1 and day +1 at -1, -0.5, -0.25, 0.08, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs
QTcX interval (subject-specific correction of QTcF, QTcB and QTcH)
Time frame: ECGs taken every treatment period on day -1 and day +1 at -1, -0.5, -0.25, 0.08, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hrs
Plasma concentration (AUC, Cmax, Tmax)
Time frame: Each treatment period on dosing day at -0.75, 0.08, 0.25, 0.5, 1, 2, 4, 6, 8 and 12 hrs
Urinary excretion (Ae)
Time frame: Each treatment period on day of dosing at -0.75, 0.58 and 24 hours.
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Tablet, oral, 400mg, single dose