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NCT00848939 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis
A Phase 1 study, sponsored by United Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00848939 is a Phase 1 study that has completed, run by United Therapeutics. The registered enrollment target is 28 participants.
The verdict
NCT00848939, a Phase 1 study, has completed, sponsored by United Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1 mg treprostinil diethanolamine SR dose. Cohort 2: escalating doses of treprostinil diethanolamine SR up to a target dose of 4 mg BID.
Interventions
- DRUG treprostinil diethanolamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00848939
The ClinicalTrials.gov registry entry for NCT00848939 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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 treprostinil diethanolamine is the first listed.
NCT00848939 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00848939 about?
NCT00848939 is a clinical study titled "Pharmacokinetics of Oral Treprostinil in Patients With Systemic Sclerosis". This study will assess the pharmacokinetic and safety profile of treprostinil following fixed and escalating doses of treprostinil diethanolamine SR tablets. Open-label, two-part study assessing the pharmacokinetics, safety, and tolerability of oral treprostinil diethanolamine SR. Cohort 1: single 1...
What is the current status of trial NCT00848939?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2008-12. Estimated completion is 2010-04.
What interventions are being tested in trial NCT00848939?
The interventions under investigation include: treprostinil diethanolamine (DRUG).
Who is sponsoring clinical trial NCT00848939?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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