The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
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|ClinicalTrials.gov Identifier: NCT01131845|
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : May 17, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Renal Dysfunction||Drug: UT-15C SR (treprostinil diethanolamine)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
U.S. FDA Resources
|Experimental: Treprostinil diethanolamine||
Drug: UT-15C SR (treprostinil diethanolamine)
Single dose, 1 mg UT-15C SR
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131845
|United States, Florida|
|Orlando Clinical Research Center|
|Orlando, Florida, United States, 32809|
|Principal Investigator:||Thomas Marbury, MD||Orlando Clincal Reserach Center|