Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of GSK573719 (LAMA) and GW642444 (LABA)Administered Individually and Concurrently in Healthy Japanese Subjects (DB2113208)
GW642444 is a potent and selective long-acting beta2 agonist; GSK573719 is a long-acting, inhaled, muscarinic receptor antagonist (or anticholinergic) bronchodilator. Both are in development as once daily (QD) monotherapies for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Development of these two inhaled drugs as a combination therapy is also planned and would have potential for improved efficacy and patient benefit as they both work through different receptor pathways and the combined bronchodilatory effect might be additive.
This study is a randomised, double blind, placebo-controlled, four-way crossover study which will assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of GSK573719 and GW642444 in sixteen healthy Japanese subjects. Subjects will receive four possible treatments as single inhaled doses, receiving the two monotherapies separately, the monotherapies concurrently, and placebo.
Blood samples for PK analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of heart rate, blood pressure, ECG and twenty-four hour Holter monitoring, potassium, safety laboratory data and review of adverse events.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK573719 and GW642444 as Monotherapies and Concurrently in Healthy Japanese Subjects|
- adverse events, cardiac and ECG parameters, vital signs, lung function and clinical laboratory safety assessments [ Time Frame: From dosing to 24hr post-dose ] [ Designated as safety issue: No ]
- plasma concentrations of GSK573719 and GW642444 and derived pharmacokinetic parameters thereof [ Time Frame: From dosing to 24 hr post-dose ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: GSK573719, GW642444, GSK573719+GW642444, placebo
This is a four-way cross-over study. Subjects, healthy volunteers, will receive a single dose of GSK573719 (500ug), GW642444 (50ug), GSK573719 (500ug)+GW642444 (50ug) administered concurrently, or placebo at each of the four treatment periods. There is a minimum wash-out period of seven days between doses. On enrolment into the study, subjects will be assigned to one of four treatment sequences which are based on a Williams design in accordance with the randomization schedule generated by GSK prior to study start.
GSK573719 is a long-acting, inhaled, muscarinic receptor antagonist or anticholinergic bronchodilator. GW642444 is a potent and selective long-acting beta-2 agonist. Both are in development for once daily monotherapies for the treatment of COPD. In this study, their effects are investigated following individual and concurrent administration.
Other Name: GW642444
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976144
|Australia, New South Wales|
|GSK Investigational Site|
|Randwick, New South Wales, Australia, 2031|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|