NCT00976144: DB2113208

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of GSK573719 (LAMA) and GW642444 (LABA)Administered Individually and Concurrently in Healthy Japanese Subjects

Completed Phase 1 Last updated 27 June 2017

What this trial tests

Phase 1 trial testing GSK573719 in Pulmonary Disease, Chronic Obstructive in 16 participants. Completed in 22 September 2009.

Timeline

29 July 2009

Primary endpoint
22 September 2009

22 September 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	29 July 2009
Primary completion	22 September 2009
Estimated completion	22 September 2009
Sites	1 location across Australia

Drugs / interventions tested

• GSK573719 — full drug profile →

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 65, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety, tolerability, pharmacodynamics and pharmacokinetics of umeclidinium and vilanterol alone and in combination: a randomized crossover trial.
   Kelleher DL, Mehta RS, Jean-Francois BM, Preece AF, et al · · 2012 · cited 34× · PMID 23284643 · DOI 10.1371/journal.pone.0050716
2. Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.
   Albertson TE, Bowman WS, Harper RW, Godbout RM, et al · · 2019 · cited 3× · PMID 31239659 · DOI 10.2147/copd.s191845