NCT02243306

Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis

A Repeat-Dose, Open-Label, Parallel-Group Study to Assess the Pharmacokinetics of GSK1278863 and Metabolites in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialysis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863	Round, biconvex, white film coated tablet containing 5 mg GSK1278863.

Timeline

• Start date: 2014-10-24
• Primary completion: 2017-05-10
• Completion: 2017-05-10
• First posted: 2014-09-17
• Last updated: 2019-04-09
• Results posted: 2019-03-11

Locations

2 sites across 1 country: United States