A Healthy Volunteer Study to Assess the Relative Bioavailability of 2 Forms of SB773812 Tablets.
Status:
Completed
Trial end date:
2007-07-25
Target enrollment:
Participant gender:
Summary
Study to compare PK of a new 120mg tablet with two 60mg tablets. This is required because we
plan to have only single tablets administered in the later phase clinical trials but we have
not had a 120mg strength before. As this is a new previously untested strength we need to
ensure that the PK is similar to that achieved using 2x60mg before we start a large
manufacturing campaign and before we administer to a large number of patients. The study is
planned to consist of a single part, with two dosing periods, periods 1 and 2 consisting of
18 subjects. There will be 20 days washout between each dose. Initially 4 subjects will be
given a single oral dose of 120 mg SB-773812 and 2 will be given placebo. If 120mg SB-773812
is well tolerated in the first four volunteers, the remaining 12 subjects will be dosed. If
the 120mg single oral dose in the first 4 subjects is poorly tolerated, the study will be
stopped. Subjects will return to the centre for follow-up 14 to 21 days after the final
dose.It is expected that the total duration of the study should be approximately 11 weeks.