NCT01131845

The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: United Therapeutics · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, single-dose evaluation of 1 mg UT-15C SR pharmacokinetics, safety, and tolerability in subjects with normal, mild, moderate and end stage renal disease (ESRD; on dialysis). Subjects in the ESRD group will receive 2 doses of UT-15C SR, separated by 14 days. One dose will be given 4 hours prior to dialysis, the other dose will be given at the end of dialysis. Pharmacokinetic samples will be taken immediately prior to dosing and 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 24, 30, 36, 42 and 48 hours post dose. Additionally, subjects with ESRD will have a sample taken at 60 hrs post dose.

Conditions

• Pulmonary Arterial Hypertension
• Renal Dysfunction

Interventions

Type	Name	Description
DRUG	UT-15C SR (treprostinil diethanolamine)	Single dose, 1 mg UT-15C SR

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-05-27
• Last updated: 2012-05-17

Locations

1 site across 1 country: United States