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Also known as TRV734
Open-label TRV734 · 2 trials · 1 indication
Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.
| Arm | Type | Description |
|---|---|---|
| Formulation A | EXPERIMENTAL | - |
| Formulation B | EXPERIMENTAL | - |
| Formulation C | EXPERIMENTAL | - |
| Formulation D | EXPERIMENTAL | - |
| Formulation E | EXPERIMENTAL | - |
| Formulation F | EXPERIMENTAL | - |
| TRV734 125 mg | EXPERIMENTAL | Part A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal. Part A will also inform the dosing paradigm for Part B. |
| Multiple ascending dose study, active and placebo comparators | ACTIVE_COMPARATOR | Part B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo. |
| Name | Type | Description |
|---|---|---|
| TRV734 | DRUG | Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days. |
| Open-label TRV734 125 mg | DRUG | 125 mg |
| TRV734 blinded | DRUG | blinded, multiple ascending dose |
| Oxycodone IR 10 mg | DRUG | - |
| Placebo | DRUG | TRV734-matched and oxycodone placebo |
Inclusion Criteria: * Healthy as determined by a responsible physician or trained qualified designee * Males: 18 - 55 years inclusive at screening * Capable of giving written informed consent Exclusion Criteria: * Clinically significant conditions or history of fainting or syncope * Medical or ps...
Open-label TRV734 is an investigational small molecule developed by Trevena, Inc. (ticker TRVN). It has been studied in Phase 1 clinical trials in healthy adult volunteers. The specific therapeutic indication for Open-label TRV734 has not been disclosed, and the program is in early-stage clinical development.
Open-label TRV734 is being developed by Trevena, Inc., which trades under the ticker symbol TRVN. Trevena is the sponsor of the clinical trials evaluating Open-label TRV734 in healthy volunteers.
Open-label TRV734 is in Phase 1 clinical development. Both of its Phase 1 trials have been completed, and no active trials are currently listed. It remains an investigational agent and is not approved by the FDA.
Open-label TRV734 has been evaluated in two completed Phase 1 trials: NCT02411500, a pharmacokinetic, safety and tolerability study in 18 healthy adult males, and NCT02211625, a safety, tolerability, pharmacodynamic and pharmacokinetic study in 75 healthy adults. Both trials were conducted in the United States.
Yes, Open-label TRV734 is also known as TRV734 and Open-label TRV734 125 mg. These names refer to the same investigational small molecule developed by Trevena, Inc. (TRVN).