Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
An Open Label, Six-period Cross-over, Single and Repeat Dose Study to Determine the Pharmacokinetics of Fluticasone Furoate and GSK961081 When Administered Alone, in Combination, or Concurrently Via the ELLIPTA
Batefenterol (BAT) is a novel bifunctional molecule that combines muscarinic antagonism and
beta2-agonism in a single molecule and is in development for the treatment of chronic
obstructive pulmonary disease (COPD). FF is a corticosteroid approved as the inhaled
corticosteroid (ICS) component of a combination product, with vilanterol (VI), a long-acting
beta2-agonist for COPD. In the current study FF will be investigated as an inhaled product
in combination with BAT, for treatment of COPD.
This study is an open-label, six-way crossover, single and repeat dose study to evaluate the
systemic pharmacokinetics, safety and tolerability of FF and BAT when administered via the
ELLIPTA™ alone, in combination, or concurrently at 3 times the clinical dose, following a
single dose, and at the proposed clinical dose, following repeat doses.
This study will consist of screening period, 6 treatment periods, and a follow-up visit.
Each subject will have 3 periods in which they receive a single dose treatment regimen (3
inhalations on Day 1 of each single dose study period) and 3 periods in which they receive a
single dose treatment regimen followed by a 7-day, once-daily, repeated dose. On Day 1 of
those periods, subjects will receive their single dose as 3 inhalations. On Days 2-8,
subjects will receive 1 inhalation per day for the repeated dose regimen. There will be a
minimum of 7-day washout between each treatment periods. All subjects will receive 9
treatments and follow-up procedures will be done 7 14 days after the last dose.
Forty eight healthy subjects will be enrolled into the study, such that approximately 40
subjects complete dosing and PK assessments. The total duration of participation for each
subject in this study will be up to 15 weeks. ELLIPTA is a registered trademark of the
GlaxoSmithKline [GSK] group of companies.
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