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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 drug being studied for the treatment of heart failure. It has been evaluated in Phase 1 clinical trials involving patients with heart failure, including those with renal dysfunction. It is not approved for any indication.
TRV120027 targets the angiotensin II receptor type 1, also known as AGTR1. It acts as an antagonist at this receptor. This mechanism is being investigated for its potential effects in heart failure.
TRV120027 is being developed by Trevena, Inc., a biopharmaceutical company. Trevena trades on the Nasdaq under the ticker symbol TRVN.
TRV120027 is in Phase 1 clinical development. It has completed two Phase 1 trials and is not currently active in further trials. It is investigational and has not been approved by the FDA.
TRV120027 has been studied in two completed Phase 1 trials: NCT01444872, which evaluated renal pharmacodynamics in patients with heart failure and renal dysfunction, and NCT01187836, which evaluated its effects in patients with heart failure. Both trials are completed.