The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
This study has been completed.
Sponsor:
United Therapeutics
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
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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:
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 (Adult, Senior) |
| 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
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
| 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 Familial Primary Pulmonary Hypertension Renal Insufficiency Vascular Diseases Cardiovascular Diseases Hypertension, Pulmonary |
Lung Diseases Respiratory Tract Diseases Kidney Diseases Urologic Diseases Treprostinil Antihypertensive Agents |
ClinicalTrials.gov processed this record on September 23, 2016