The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

Completed · Phase 1

Conditions studied: Pulmonary Arterial Hypertension, Renal Dysfunction

In brief

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.

Key facts

Study ID
NCT01131845
Run by
United Therapeutics
People needed
16
Starts
2010-05-01
Expected to finish
2010-09-01
Last updated by the study team
2012-05-17

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.