Pulmonary Arterial Hypertension Clinical Trial
Official title:
An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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