NCT00848939

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

An Evaluation of the Pharmacokinetics and Safety of Fixed and Escalating Doses of Oral Treprostinil Diethanolamine (UT-15C) Sustained Release Tablets in Patients With Systemic Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	treprostinil diethanolamine	Cohort 1: Single 1 mg treprostinil diethanolamine sustained release tablet dose
DRUG	treprostinil diethanolamine	Cohort 2: treprostinil diethanolamine sustained release doses will be escalated up to a target dose of 4 mg BID

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2009-02-20
• Last updated: 2012-10-23

Locations

3 sites across 1 country: United States