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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...
TRV734 is an investigational small molecule being studied in healthy volunteers. It is being developed by Trevena, Inc. for potential therapeutic use, though the specific indication has not been disclosed. As of now, it has completed Phase 1 clinical trials.
TRV734 is being developed by Trevena, Inc., a biopharmaceutical company traded on NASDAQ under the ticker TRVN. The company is conducting clinical research on this investigational drug.
TRV734 is in Phase 1 clinical development. It has completed two Phase 1 trials in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
TRV734 has completed two Phase 1 trials: NCT02211625, a safety, tolerability, pharmacodynamics and pharmacokinetics study in healthy adults with 75 participants, and NCT02411500, a pharmacokinetic, safety and tolerability study in healthy adult males with 18 participants.
TRV734 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in healthy volunteers. Further clinical development and regulatory review would be required before any approval could be considered.