NCT00963027

Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil

An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.

Detailed description

This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR in healthy volunteers.

Conditions

• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Treprostinil diethanolamine	Subjects will each receive a single 1 mg sustained release tablet of treprostinil diethanolamine by mouth immediately following breakfast before and after repeated daily dosing with esomeprazole.
DRUG	Esomeprazole	Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2009-08-20
• Last updated: 2010-03-08

Locations

1 site across 1 country: United States