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The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

2014-08-27 03:13:22 | BioPortfolio

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.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pulmonary Arterial Hypertension

Intervention

UT-15C SR (treprostinil diethanolamine)

Location

Orlando Clinical Research Center
Orlando
Florida
United States
32809

Status

Recruiting

Source

United Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:22-0400

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Medical and Biotech [MESH] Definitions

A malformation of the heart in which the embryonic common PULMONARY VEIN was not incorporated into the LEFT ATRIUM leaving behind a perforated fibromuscular membrane bisecting the left atrium, a three-atrium heart. The opening between the two left atrium sections determines the degree of obstruction to pulmonary venous return, pulmonary venous and pulmonary arterial hypertension.

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