Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers
Status:
Completed
Trial end date:
2015-08-12
Target enrollment:
Participant gender:
Summary
This study will be a two-part with an open-label, single oral dose, two-way crossover study
design. Part A and Part B of the study are independent and may be conducted in parallel. The
Part A of the study will assess the effect of an oral dose of GSK1278863 on the
pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in
order to determine the potential for clinically-significant drug interactions with CYP2C8 and
OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor
(trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites.
Part A will be conducted in approximately 30 healthy subjects, having a randomized study
design. There will be approximate 7-day washout period between each dosing period. Part B
will be conducted in approximately 20 healthy subjects, having single sequence study design.
Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The
total duration of a subject's involvement in the part A of the study will be approximately 8
weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to
Follow-up).