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TRV120027 · 2 trials · 2 indications
Assessments of glomerular filtration rate are made hourly during the 6-hour study drug infusion on study Day 1 and study Day 3. GFR in hours 4-6 are compared to GFR in hours 1-3, and comparisons made between Placebo and TRV120027.
Vital signs measurements made during and following drug infusion will be evaluated as a change from baseline, and comparing placebo to TRV120027. Assessments are made on study Day 1 and study Day 3.
The effect of TRV120027 on pulmonary capillary wedge pressure will be compared to baseline and to placebo at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion.
Safety and tolerability will be assessed qualitatively by evaluating adverse events, clinical laboratories, ECGs, cardiac telemetry and vital signs at multiple measurement time points during the 14 hour infusion and for 4 hours after discontinuation of the infusion. Follow-up assessments for adverse events at Day 7 and Day 30 will be conducted.
| Arm | Type | Description |
|---|---|---|
| TRV120027 | EXPERIMENTAL | TRV120027 administered as an IV infusion |
| Normal Saline | PLACEBO_COMPARATOR | Normal Saline administered as an IV infusion |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TRV120027 | DRUG | IV infusion |
| Normal Saline | DRUG | IV infusion |
| Placebo | DRUG | Placebo administered for 14 hours. |
Inclusion Criteria: * Written Informed Consent * Heart Failure * Mild to moderate renal dysfunction * Age 18- \<75 * Males and females (non-childbearing potential) Exclusion Criteria: * Any significant disease or condition that would interfere with the interpretation of safety or efficacy or effi...
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TRV120027 is an investigational small molecule being developed by Trevena, Inc. for the treatment of heart failure. It is a cardiovascular therapeutic that has been studied in patients with heart failure, including those with concurrent kidney disease. As of the available data, TRV120027 is in Phase 1 clinical development and is not yet approved.
TRV120027 is a small molecule that targets the angiotensin II type 1 receptor. It is being studied for its effects in heart failure, where it may modulate the renin-angiotensin system to improve cardiac function. The drug is in Phase 1 clinical trials, and its mechanism is being evaluated for potential therapeutic benefit.
TRV120027 is developed by Trevena, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TRVN. Trevena is conducting clinical research on this investigational drug for heart failure. The company has completed Phase 1 trials for TRV120027, but the drug remains in early-stage development.
TRV120027 is in Phase 1 clinical development. It has completed two Phase 1 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities. Trevena, Inc. is the developer of TRV120027, which is being studied for heart failure.
TRV120027 has been studied in two completed Phase 1 clinical trials. NCT01187836 evaluated its effects in 33 patients with heart failure across the United States, Czechia, and Poland. NCT01444872 assessed its renal pharmacodynamics in 17 patients with heart failure and kidney disease in the United States. Both trials were randomized, double-blind, and placebo-controlled.
TRV120027 is not known to have alternative names. It is a distinct investigational compound developed by Trevena, Inc. for heart failure. The drug has been studied under its unique identifier in clinical trials, and no other names have been associated with it in the available data.