A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.
Status:
Completed
Trial end date:
2008-07-29
Target enrollment:
Participant gender:
Summary
Study to compare PK of a new 100mg capsule with four 25mg capsules. This is required because
we plan to have only single capsules administered in the later phase clinical trials but we
have not had a 100mg strength before. As this is a new previously untested strength we need
to ensure that the PK is similar to that achieved using 4 x 25mg. The study will also assess
the effect of high fat food on the PK of the 100mg capsule. The study is planned to consist
of a single part , with three dosing periods, periods 1-3 consisting of 16 subjects. There
will be a week wash out between each dose. In the three dosing periods subjects will either
received 4x25 mg GSK598809 capsule in a fasted state, 100mg capsule in a fasted state or
100mg GSK598809 capsule in a fed state. Subjects will return to the centre for follow-up 7-14
days after the final dose. It is expected that the total duration of the study should be
approximately eight weeks.