The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension Renal Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treprostinil diethanolamine

Group Type EXPERIMENTAL

UT-15C SR (treprostinil diethanolamine)

Intervention Type DRUG

Single dose, 1 mg UT-15C SR

Interventions

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UT-15C SR (treprostinil diethanolamine)

Single dose, 1 mg UT-15C SR

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes