NCT00963001

Effect of Food on the Pharmacokinetics of Oral Treprostinil

Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the pharmacokinetic and safety profile of a single dose of oral treprostinil following four different meals of varying caloric and fat content.

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 within 10 minutes of consuming each of four standardized meals on Study Days 1, 8, 15, and 22.
OTHER	Standardized meals	Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22.

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-08-20
• Last updated: 2010-03-08

Locations

1 site across 1 country: United States