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treprostinil diethanolamine · 7 trials · 4 indications
Net ulcer burden was defined as the number of "new" or "active" digital ulcers (DU), plus the number of "indeterminate" DUs at that assessment that have previously been classified as either "active" or "new" at any earlier assessment during the study. A DU was defined as an area with visually discernable depth and a loss of continuity of epithelial coverage, which could be denuded or covered by a scab or necrotic tissue. If denuded, the DU was pronounced "active." If denudation could not be judged because of the presence of scab or necrotic tissue, DU presenting with features, including underlying pain, based on Investigator clinical judgment to be consistent with loss of epithelialization, epidermis, or dermis, and requiring treatment were designated as "active." Otherwise, the DU was pronounced "indeterminate." Only DUs distal to the proximal interphalangeal joints, volar to the equator of the finger, not localized in creases and vascular in origin were assessed.
Pharmacokinetic blood sampling will occur twice for each subject. Pharmacokinetic parameters will be derived from treprostinil concentration-time data
Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine sustained release tablets immediately prior to through 36 hours post treprostinil diethanolamine dosing.
| Arm | Type | Description |
|---|---|---|
| treprostinil diethanolamine | EXPERIMENTAL | Treprostinil diethanolamine sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose. |
| placebo (sugar pill) | PLACEBO_COMPARATOR | Matching placebo sustained release tablet initiated at 0.25 mg BID and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose. |
| 1 mg tablet; 1mg solution | EXPERIMENTAL | - |
| 1mg solution; 1mg tablet | EXPERIMENTAL | - |
| 0.5 mg treprostinil diethanolamine | EXPERIMENTAL | 0.5 mg treprostinil diethanolamine |
| 2.5 mg treprostinil diethanolamine | EXPERIMENTAL | 2.5 mg treprostinil diethanolamine |
| 1 mg treprostinil diethanolamine | EXPERIMENTAL | 1 mg treprostinil diethanolamine |
| manufacturer #1 | ACTIVE_COMPARATOR | treprostinil diethanolamine from manufacturer #1 |
| manufacturer #2 | EXPERIMENTAL | treprostinil diethanolamine from manufacturer #2 |
| Name | Type | Description |
|---|---|---|
| treprostinil diethanolamine | DRUG | oral sustained release tablet. Maximum tolerable dose not exceeding 16 mg twice daily (BID) |
| placebo | DRUG | - |
| Standardized meals | OTHER | Each subject will receive one of four different standardized meals of varying caloric and fat content in a randomized sequence such that all subjects will receive all four meals over the course of the study. Each subject will receive one standardized meal for breakfast on Study Days 1, 8, 15, and 22. |
| Esomeprazole | DRUG | Each subject will receive a single 40 mg capsule of esomeprazole by mouth in the morning for seven days. |
Inclusion Criteria: * Subject gave voluntary written informed consent to participate in the study * Diagnosis of systemic sclerosis (SSc) as defined by American College of Rheumatology (ACR) criteria * Males and females age greater than 18 years at Screening * Presence of at least one active digita...
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Treprostinil diethanolamine is an investigational small molecule being developed for pulmonary arterial hypertension, a form of pulmonary hypertension. It is also studied in the context of systemic sclerosis. The drug is in Phase 1 clinical development and is not yet approved by the FDA.
Treprostinil diethanolamine is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker UTHR. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics and bioavailability in healthy volunteers and patients with pulmonary arterial hypertension.
Treprostinil diethanolamine is in Phase 1 clinical development. All three completed trials are Phase 1 studies focused on pharmacokinetics, food effects, drug interactions, and bioavailability. The drug is investigational and has not received FDA approval.
Treprostinil diethanolamine has three completed Phase 1 trials: NCT00963001 (food effect on pharmacokinetics), NCT00963027 (effect of esomeprazole on pharmacokinetics), and NCT01153386 (pharmacokinetic linearity and comparative bioavailability). A fourth trial, NCT01165476, also completed, compared bioavailability from two manufacturing facilities.
Treprostinil diethanolamine is an oral formulation of treprostinil, a prostacyclin analog. The clinical trials listed for this drug specifically study the diethanolamine salt form, which is designed for oral administration. The drug is being developed by United Therapeutics for pulmonary arterial hypertension.