Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single Center, Double-blind, Randomized, Placebo-controlled, Parallel, Single and Repeat, Dose-ascending Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK2269557 Administered Via the ELLIPTA™ Dry Powder Inhaler to Healthy Japanese Subjects
GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3-Kinase (PI3K) delta
inhibitor being developed as an anti-inflammatory and anti-infective agent for the treatment
of inflammatory airway diseases, such as chronic obstructive pulmonary disease (COPD). The
purpose of the study is to assess the safety, tolerability and pharmacokinetics (PK) of
single and repeat doses of GSK2269557 administered via the ELLIPTA dry powder inhaler (DPI)
to healthy Japanese subjects. This is the first time for Japanese subjects that GSK2269557
will be administered via the ELLIPTA DPI with the addition of magnesium stearate.
In each group of this study, subjects will receive a single dose of either GSK2269557 or
placebo in Session 1 and receive daily dose of GSK2269557 or placebo for 10 days in Session
2. Session 1 of the next dose strength may be run in parallel with the Session 2 of the
previous dose. The doses planned for the study are 200 micrograms (mcg), 500 mcg and 700
mcg. There will be at least 10 days washout between the two dosing sessions. Follow up
period will start 10 days (+-1 day) after the last dose of Session 2. A total number of 36
subjects will be enrolled for the study with 27 subjects receiving a dose strength of
GSK2269557 and 9 subjects will receive each dose strength of GSK2269557. ELLIPTA is a
trademark of the GSK group of companies.
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