Study to Evaluate Safety, Tolerability and Pharmacokinetics of GSK2269557 to Japanese Healthy Subjects
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
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.