This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when inhaled in two different formulations as a fine powder by asthmatic patients. In addition, the study is designed to examine the effect of the study drug on the lungs, how the study drug affects parts of the body other than the lungs and to see how the body affects the study drug when it is given in single doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
comparator
investigational drug or placebo
Magnesium Stearate
GSK Investigational Site
Auchenflower, Queensland, Australia
GSK Investigational Site
Clayton, Victoria, Australia
GSK Investigational Site
Wellington, New Zealand
Mean change from baseline (pre-dose) FEV1 in trough (mean of the FEV1 values obtained 23 and 24 hours after dosing) FEV1
Time frame: on going
Mean change from baseline (pre-dose) in FEV1 (i.e. derive separate responses for each FEV1 obtained over 24 hours after dosing).
Time frame: on going
General safety and tolerability, including adverse events, laboratory safety tests (haematology, clinical chemistry and urinalysis), vital signs and, 12-lead ECG.
Time frame: on going
Weighted mean and maximum value (0 - 4 h) QTc(B)
Time frame: on going
Weighted mean and maximum value (0 - 4 h) QTc(F)
Time frame: on going
Weighted mean and maximum value (0 - 4 h) supine heart rate
Time frame: on going
Weighted mean and maximum value (0 - 4 h) supine systolic blood pressure
Time frame: on going
Weighted mean and minimum value (0 - 4 h) supine diastolic blood pressure
Time frame: on going
Weighted mean and maximum value glucose (0 - 4 h)
Time frame: on going
Weighted mean and minimum value potassium (0 - 4 h)
Time frame: on going
Single dose derived plasma pharmacokinetic parameters (AUC(0-t), Cmax, tmax) for GW642444 and GI179710 (triphenylacetate counterion)
Time frame: on going
Estimate GW642444 concentration (Cmax) -systemic pharmacodynamic relationship for PD parameters, including heart rate, potassium & glucose levels
Time frame: on going
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