drugset / Trial / NCT02348372

Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects

NCT02348372 ↗

Phase 1 Completed 34 enrolled GlaxoSmithKline
RandomizedCrossoverSingle-blindOther

Summary

GSK1278863A 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, PHI115385, will be the first administration of GSK1278863A to Japanese subjects to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses in healthy Japanese adult subjects. Healthy Caucasian adult subjects will be included in order to compare pharmacokinetics of GSK1278863A and its metabolite(s), and pharmacodynamics of GSK1278863A.

Timeline

Start
2011-03-31
Primary completion
2011-06-03
Completion
2011-06-03

Drugs

EvaluationDrugModalityDoseRoute
Subject GSK1278863A Small molecule 10 mg Oral
Subject GSK1278863A Small molecule 25 mg Oral
Subject GSK1278863A Small molecule 50 mg Oral
Subject GSK1278863A Small molecule 100 mg Oral

Indications