NCT01406340

Assessment of the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Renal Impairment

A Repeat-dose, Open-label, Parallel-group Study to Assess the Pharmacokinetics of GSK1278863 and Metabolites in Normal Subjects and Subjects With Impaired Renal Function

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This will be an open-label, parallel-group study to evaluate the pharmacokinetics of GSK1278863 and metabolites in normal subjects and subjects with impaired renal function, including those who are hemodialysis dependent. GSK1278863 will be administered once daily for 14 days to normal subjects and subjects with Stage 3 and Stage 4 renal function, and 15 days to subjects with Stage 5 renal function. Pharmacokinetic assessments will be made on Days 1 and 14 (normal subjects, subjects with Stage 3 and Stage 4 renal function) or Days 14 and 15 (dialysis and non-dialysis days; Stage 5).

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	5 mg GSK1278863	5 mg per day administered orally for 14 days for normal subjects and subjects with Stage 3/4 renal function; 5 mg per day administered orally for 15 days for subjects with Stage 5 renal function

Timeline

• Start date: 2011-08-30
• Primary completion: 2013-08-31
• Completion: 2013-08-31
• First posted: 2011-08-01
• Last updated: 2019-06-28

Locations

3 sites across 1 country: United States