NCT01673555

Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers

A Randomized, Placebo-controlled, Study to Evaluate the Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This protocol is designed to explore whether short-term therapy with GSK1278863 affects PASP under normoxic and hypoxic conditions in healthy volunteers. Healthy subjects will be evaluated using echocardiography to estimate PASP based on the velocity of the tricuspid regurgitant jet. Resting PASP will be assessed under normoxic (room air) conditions, as well as after 30 minutes' exposure to 15% O2 before, during, and after short-term treatment with GSK1278863.

Detailed description

This is a single-center, randomized, placebo-controlled, single-blinded (subjects and investigators will be blinded, GSK internal personnel will not be blinded) study designed to test whether short-term administration (5 days) of GSK1278863 affects PASP under normoxic and hypoxic conditions in healthy volunteers. Approximately 45 healthy subjects with mild-moderate baseline tricuspid regurgitation (sufficient to allow reliable assessment of PASP) will be enrolled into this study and will provide \~15 evaluable subjects in each arm \[Placebo, 5 mg, and 100 mg GSK 1278863\].

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	GSK1278863	GSK1278863
DRUG	Placebo	Placebo

Timeline

• Start date: 2012-05-15
• Primary completion: 2012-11-19
• Completion: 2012-11-19
• First posted: 2012-08-28
• Last updated: 2017-06-09

Locations

1 site across 1 country: United States