Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Single-Centre, Double-Blind, Placebo Controlled Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of GSK2269557 as a Dry Powder in Healthy Subjects Who Smoke Cigarettes
GSK2269557 is potent and highly selective inhaled phosphoinositides 3-kinases -delta
(PI3K-delta) inhibitor being developed as an anti-inflammatory agent for the treatment of
inflammatory airway diseases. GSK2269557 has already been administered as a nebulized
solution in single and repeat doses to humans and has been well tolerated across the range of
doses used. The purpose of this study is to evaluate the safety, tolerability and
pharmacokinetics of single and repeat inhaled doses of GSK2269557 as a dry powder. This study
is the first administration of dry powder GSK2269557 in humans.
Part A will consist of four treatment periods separated by at least 14 days wash out periods.
In each treatment period there will be 12 subjects receiving GSK2269557 and 4 subjects
receiving placebo. The doses of GSK2269557 planned for Part A are 100 micrograms (mcg), 500
mcg and 3000 mcg. Blinded safety and available pharmacokinetic (PK) data will be reviewed
before each dose escalation. Part B will be a parallel group design conducted in a separate
group of subjects from Part A. Nine subjects will receive repeat doses of GSK2269557 and 3
subjects will receive repeat doses of placebo for 14 days. The total daily dose will be the
same as the dose that was well tolerated in Part A. The study duration, including screening
and follow-up, is not expected to exceed 82 days for subjects in part A and 55 days for
subjects in part B of the study.
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