Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis
Status:
Completed
Trial end date:
2017-05-10
Target enrollment:
Participant gender:
Summary
GSK1278863 is an orally-active, novel small molecule agent which inhibits hypoxia-inducible
factor (HIF) prolyl -4- hydroxylases (PHDs) and is in development for the treatment of
anaemia associated with chronic kidney disease (CKD). As the kidney represents a major site
of elimination for many drugs and their metabolites, and GSK1278863 will be administered to
subjects with various stages of renal disease, it is important to characterize the
pharmacokinetics in this target patient population. The purpose of this study is to
characterize the pharmacokinetics of GSK1278863 and its metabolites in subjects with end
stage renal disease (ESRD) undergoing peritoneal dialysis. This will be a repeat-dose,
open-label, parallel-group study. Approximately 30 subjects with ESRD will be enrolled in two
cohorts (15 subjects in each cohort) to ensure that 6 subjects on continuous ambulatory
peritoneal dialysis (CAPD) (cohort 1) and 6 subjects on automated peritoneal dialysis APD
(cohort 2) complete dosing and critical assessments. GSK1278863 will be administered once
daily for 14 days. Primary pharmacokinetic assessments will be made on Days 1 and 14.