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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:

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
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, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
 Treprostinil
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013