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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01131845 |
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Date of registration:
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10/05/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
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Scientific title:
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An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment. |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01131845 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Thomas Marbury, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Orlando Clincal Reserach Center |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
79 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Dysfunction
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: UT-15C SR (treprostinil diethanolamine)
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Primary Outcome(s)
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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)]
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Secondary ID(s)
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TDE-PH-120
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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