Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single-centre, Open-label, Sequential, Cross-over Study to Examine the Safety, Tolerability and Pharmacokinetics of 3 Ascending Single Intravenous Doses, a Single 1000μg Oral Dose and a Single 1000μg Inhaled Dose of GSK573719 in Healthy Male Volunteers.
A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability and pharmacokinetics of 3 ascending single intravenous doses, a single 1000μg oral dose and a single 1000μg inhaled dose of GSK573719 in healthy male volunteers.
GSK573719 is a high-affinity, specific, reversible muscarinic receptor (mAChR) antagonist
which is being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
The long duration of action of GSK573719, when administered via inhalation to humans,
supports the potential for use as a long acting bronchodilator for COPD.
This will be an open-label, single dose, dose-ascending study in healthy male subjects to
establish well tolerated intravenous (IV) dose of GSK573719 to be administered in a
subsequent definitive human radiolabel metabolic study. The pharmacokinetics and the
bioavailability of a single oral and a single inhaled dose of GSK573719 will also be
evaluated.
Blood and urine samples for pharmacokinetic analysis will be taken at regular intervals up
to 48 hours after dosing. Safety will be assessed by measurement of heart rate, blood
pressure, ECG, lead II monitoring and twenty four hour Holter monitoring, safety laboratory
data and review of adverse events.
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