Please select the arm or intervention descriptions that belong to the clinical trial below.
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
Brief Summary: 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.


Options:
A: Arm Label: Umeclidinium 62.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium | Arm Label: Glycopyrronium 44 mcg; Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium | Intervention Type: DRUG; Name: Umeclidinium; Assigned to Arm(s): Umeclidinium 62.5 mcg | Intervention Type: DRUG; Name: Glycopyrronium; Assigned to Arm(s): Glycopyrronium 44 mcg
B: Arm Label: FF/VI 100/25 mcg + UMEC (62.5mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + UMEC (125mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + Placebo; Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: Placebo | Intervention Type: DRUG; Name: FF; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: VI; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: UMEC; Assigned to Arm(s): FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo
C: Arm Label: GSK573719, GW642444, GSK573719+GW642444, placebo; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 | Intervention Type: DRUG; Name: GSK573719; Assigned to Arm(s): GSK573719, GW642444, GSK573719+GW642444, placebo
D: Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 | Intervention Type: DRUG; Name: GSK573719; Assigned to Arm(s): GSK573719

Answer: C