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GSK573719 IV Enabling Study

2014-08-27 03:14:12 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Disease, Chronic Obstructive

Intervention

GSK573719 (INHALATION POWDER), GSK573719 (SOLUTION)

Location

GSK Investigational Site
London
United Kingdom
NW10 7EW

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:12-0400

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