NCT02348372

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

A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation (Part 1), Fixed Sequence and Open-Label (Part 2), Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of GSK1278863A in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863A Placebo	Matching size, shape and color
DRUG	GSK1278863A	A round, biconvex, white film coated tablet

Timeline

• Start date: 2011-03-31
• Primary completion: 2011-06-03
• Completion: 2011-06-03
• First posted: 2015-01-28
• Last updated: 2017-06-22

Locations

1 site across 1 country: Australia