The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
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.