A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects
Status:
Completed
Trial end date:
2010-06-29
Target enrollment:
Participant gender:
Summary
This is an open-label, single dose, randomized, five-period, crossover study in healthy
volunteers to assess the relative bioavailability of four GSK developed oral formulations of
GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb,
PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study.
Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the
five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples
will be collected following each dose and safety assessments will be performed. The relative
bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx
formulation while the relative bioavailability the three other formulations will be compared
to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.