NCT00935831

Single Dose Safety Study for Compound to Treat Anemia in Patients With Renal Impairment

A Phase I, Single-Dose, Randomized and Single-Blind (Part 1), Fixed Sequence and Open-Label (Part 2), Studyto Evaluate the Safety, Pharmacokinetics, andPharmacodynamics of 1278863A in Subjects With RenalImpairment and Matched Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to characterize the safety and tolerability of single doses of compound 1278863A in subjects with renal impairment.

Detailed description

Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is being developed for the treatment of anemia. This study, PHI112843, will be the first administration of 1278863A to investigate the safety, tolerability, pharmacokinetics and/or pharmacodynamics of single oral doses of 50 mg and 150 mg in pre-dialysis subjects with moderate or severe renal impairment and 150 mg in hemodialysis-dependent subjects. Four to eight subjects will complete each dose cohort. Multiple blood samples for pharmacokinetic and/or pharmacodynamic analyses will be obtained post-dose in each cohort. Safety will be assessed by measurement of vital signs, cardiac monitoring, collection of adverse event assessments and laboratory safety tests.

Conditions

• Kidney Disease

Interventions

Type	Name	Description
DRUG	GSK1278863A	50mg, 150mg
DRUG	Placebo	matching placebo

Timeline

• Start date: 2009-08-12
• Primary completion: 2010-04-27
• Completion: 2010-04-27
• First posted: 2009-07-09
• Last updated: 2017-07-27

Locations

1 site across 1 country: New Zealand