Overview

Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
United Therapeutics
Treatments:
Treprostinil