This study is the first administration of GW824575 in humans. This will be a single centre,
masked, placebo-controlled study, to investigate the safety, tolerability, pharmacokinetics
(PK) and pharmacodynamics (PD) of GW824575, given as single and repeated oral doses to
healthy male subjects. The study will be comprised of 4 parts and enroll approximately 40
subjects: Part A will consist of two cohorts of 8 healthy male subjects to assess the safety,
tolerability, PK, and PD of ascending single oral doses of GW824575. All available safety,
tolerability, and PK data will be monitored prior to each dose escalation. In order to
support the possible indication for age-related macular degeneration (AMD), Part B will be
one cohort of 12 subjects to examine the safety, tolerability, PK, and PD of a repeated dose
of GW824575 over 21 days in healthy male subjects who are greater than or equal to 50 years
of age. The total daily dose in this cohort will not exceed the maximum tolerated dose (MTD)
from Parts A and D. Subjects in this cohort will undergo ophthalmology assessments before
receiving investigational product and after Day 7 of the 21-day in-patient treatment, after
steady state has been reached. As part of protocol amendment 2, Part C (Cohort 4) is removed
from the protocol. Part D, added under protocol amendment 2, will consist of one cohort of 12
healthy male subjects to assess safety, tolerability, PK, and PD of ascending single doses of
GW824575 as well as the effect of food on the PK of GW824575.