The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

United Therapeutics

Status and phase: Completed; Phase 1

Conditions: Renal Dysfunction; Pulmonary Arterial Hypertension

Treatments: Drug: UT-15C SR (treprostinil diethanolamine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131845

TDE-PH-120

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Male and female volunteers with ESRD (requiring dialysis), moderate (creatinine clearance; CrCL = 30-50 mL/min), mild (CrCL = 50-80 mL/min) and normal renal function (control group; (CrCL >80 mL/min)) may be enrolled. Eligible subject will be 18-79 years of age with a BMI between 18 - 40 kg/m2 and not taking chronic nonsteroidal antiinflammatory drugs (NSAIDs)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Treprostinil diethanolamine

Experimental group

Treatment:

Drug: UT-15C SR (treprostinil diethanolamine)