NCT02348372

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

Completed Phase 1 Last updated 22 June 2017

What this trial tests

Phase 1 trial testing GSK1278863A Placebo in Anaemia in 34 participants. Completed in 3 June 2011.

Timeline

31 March 2011

Primary endpoint
3 June 2011

3 June 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	other
Enrollment	34
Start date	31 March 2011
Primary completion	3 June 2011
Estimated completion	3 June 2011
Sites	1 location across Australia

Drugs / interventions tested

• GSK1278863A Placebo — full drug profile →
• GSK1278863A

Conditions studied

• Anaemia — all drugs for Anaemia →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 55, any sex, with Anaemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.