Safety, Tolerability and Pharmacokinetics (PK) Study of GSK2269557 in Healthy Subjects
Status:
Completed
Trial end date:
2017-07-24
Target enrollment:
Participant gender:
Summary
GSK2269557 is being developed as an anti-inflammatory and anti-infective agent for the
treatment of inflammatory airways diseases. This is the first study using a new formulation
of GSK2269557 in healthy subjects and will evaluate the safety, tolerability and PK of a
single dose of GSK2269557. Data derived from this study will inform on the PK profile and
systemic exposure expected during Phase 2b. Approximately twelve healthy subjects will be
randomized to receive a single dose of GSK2269557 750 micrograms (µg) or a single dose of
GSK2269557 500 µg via the ELLIPTA® dry powder inhaler (DPI) formulated in a blend containing
0.4 percent magnesium stearate (MgSt) in 1:1 ratio. This randomized, parallel group study
will be carried out in 3 phases, including screening phase, treatment phase and follow-up
phase. The total study duration for each subject will be up to 6 weeks. ELLIPTA is a
registered trademark of GlaxoSmithKline group of companies.