A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.
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This study will investigate the safety and tolerability of inhaled doses of GSK233705 with a new formulation.
Condition or disease
Pulmonary Disease, Chronic Obstructive
A single-centre, randomized, double-blind placebo-controlled, dose-ascending, cross-over study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 (50, 100 and 200Âµg), formulated with the excipient magnesium stearate, in healthy volunteers.
A Single-centre, Randomized, Double-blind Placebo-controlled, Dose-ascending, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705, Formulated With the Excipient Magnesium Stearate, in Healthy Volunteers
General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours. [ Time Frame: over 24 hours. ]
Secondary Outcome Measures :
Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters from 0 to 24 hours. Serial Specific airway conductance (sGaw) and Forced Expiratory Volume in 1 second (FEV1) measurements over 24 hours post-dose. [ Time Frame: over 24 hours ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male subjects 18-55 years old
Any subject with breathing problems.
High blood pressure and heart abnormalities.
Any subjects currently taking prescription and non-prescription medications.