The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

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.

Timeline

Start

2010-05

Primary completion

2010-09

Completion

2010-09

Drugs

Indications