Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single-centre, Open-label, Sequential, Dose-ascending Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Intravenous, Inhaled and Oral Doses of GW642444 in Healthy Male Subjects
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 it is given as a liquid by mouth or by injection into a vein. In addition the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it.
This will be a single-centre, open-label, dose-ascending study in 9 healthy male subjects to establish safe and well tolerated systemic exposure safety margins for GW642444 following intravenous and oral dosing to support future studies. Additionally a single inhaled dose of GW642444M will be administered to provide data to estimate inhaled bioavailability of GW642444 and the extent of renal excretion following dosing via this route. It is planned to administer four, dose-ascending, intravenous administrations of GW642444 during treatment periods 1, 2, 3 and 5; the inhaled dose would be administered in treatment period 4 and the oral dose in treatment period 6. The sequence of treatment administration may be altered if required for logistical reasons, however doses of intravenous and oral GW642444 will be administered strictly in dose ascending order. All intravenous doses will be administered as an infusion given at a constant rate over a 1 hour period. ;
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