Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Radiolabeled TRV130 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Radiolabeled TRV130 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Radiolabeled TRV130 | DRUG | A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes |
Key Inclusion Criteria: * Males, between 18 and 64 years of age, inclusive * With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs * Negative test fo...
Radiolabeled TRV130 is a carbon-14 labeled version of TRV130, a small molecule developed by Trevena, Inc. It was used as a research tool in a Phase 1 clinical study to investigate how the body metabolizes and excretes TRV130. Radiolabeled TRV130 is not a commercial product and is not approved for any therapeutic use.
Radiolabeled TRV130 is developed by Trevena, Inc., a biopharmaceutical company that trades under the ticker symbol TRVN. Trevena used this radiolabeled compound as part of its clinical pharmacology program for TRV130. The company sponsored the single Phase 1 study conducted with this labeled version.
Radiolabeled TRV130 has completed Phase 1 development. It was evaluated in one Phase 1 clinical trial that has finished, and there are no active trials of this radiolabeled compound. It is an investigational research agent and is not FDA approved for any indication.
Radiolabeled TRV130 was studied in one completed Phase 1 trial, NCT02169934, titled A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male Subjects. The trial enrolled six healthy male volunteers in the United States and was an uncontrolled study without randomization or blinding.
Radiolabeled TRV130 is used as an analytical and clinical pharmacology tool to trace the metabolism and excretion of TRV130 in humans. In trial NCT02169934, it was administered to six healthy male subjects to study how the compound is processed by the body. It has no approved therapeutic indication.