Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01131845 · ClinicalTrials.gov registry record · Phase 1
The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil
A Phase 1 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01131845 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 16 participants.
The verdict
NCT01131845, a Phase 1 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG UT-15C SR (treprostinil diethanolamine)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01131845
The ClinicalTrials.gov registry entry for NCT01131845 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United Therapeutics, which has 63 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which UT-15C SR (treprostinil diethanolamine) is the first listed.
NCT01131845 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01131845 about?
NCT01131845 is a clinical study titled "The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil". 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 d...
What is the current status of trial NCT01131845?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2010-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT01131845?
The interventions under investigation include: UT-15C SR (treprostinil diethanolamine) (DRUG).
Who is sponsoring clinical trial NCT01131845?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.