The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

United Therapeutics

ClinicalTrials.gov Identifier:

NCT01131845

First received: May 10, 2010

Last updated: May 16, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension Renal Dysfunction	Drug: UT-15C SR (treprostinil diethanolamine)	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment.

Resource links provided by NLM:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Treprostinil Treprostinil sodium

Genetic and Rare Diseases Information Center resources: Pulmonary Arterial Hypertension

U.S. FDA Resources

Further study details as provided by United Therapeutics:

Primary Outcome Measures:

Treprostinil pharmacokinetics in volunteers with varying degrees of renal function following a single oral dose of a 1 mg treprostinil diethanolamine sustained release. [ Time Frame: 48hrs post dose (60 hours for ESRD) ] [ Designated as safety issue: No ]


Enrollment:	16
Study Start Date:	May 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treprostinil diethanolamine	Drug: UT-15C SR (treprostinil diethanolamine) Single dose, 1 mg UT-15C SR

Eligibility


Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01131845

Locations


United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809

Sponsors and Collaborators

United Therapeutics

Investigators


Principal Investigator:	Thomas Marbury, MD	Orlando Clincal Reserach Center

More Information

No publications provided


Responsible Party:	United Therapeutics
ClinicalTrials.gov Identifier:	NCT01131845 History of Changes
Other Study ID Numbers:	TDE-PH-120
Study First Received:	May 10, 2010
Last Updated:	May 16, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Additional relevant MeSH terms:


Hypertension Cardiovascular Diseases Vascular Diseases Treprostinil	Antihypertensive Agents Cardiovascular Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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