The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
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.
|Pulmonary Arterial Hypertension Renal Dysfunction||Drug: UT-15C SR (treprostinil diethanolamine)||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.|
- Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release. [ Time Frame: 48hrs post dose (60 hours for ESRD) ]
|Study Start Date:||May 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: Treprostinil diethanolamine||
Drug: UT-15C SR (treprostinil diethanolamine)
Single dose, 1 mg UT-15C SR
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131845
|United States, Florida|
|Orlando Clinical Research Center|
|Orlando, Florida, United States, 32809|
|Principal Investigator:||Thomas Marbury, MD||Orlando Clincal Reserach Center|