Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ETX2514 and sulbactam · 1 trial · 1 indication
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours.
AUC0-6h defined as the area under the concentration versus time curve from time zero to 6 hours postdose. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2 .
Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose, and 1,2,2,5, 2.95, 3.05, 3.25, 3.5, 4, 5, and 6 hours after the start of the third (last) dose.
defined as the area under the concentration versus time curve from time zero to 6 hours. Venous blood will be collected for ETX2514SUL pharmacokinetic (PK) analysis predose and after the 3 dose. The 3rd dose of ETX2514 and sulbactam will be administered on Day 2. Bronchoalveolar lavage fluid will be collected for ETX2514SUL PK at 1, 2.5, 3.25, 4, or 6 hours after the 3 dose (last dose) on Day 2.
| Arm | Type | Description |
|---|---|---|
| ETX2514 and sulbactam | EXPERIMENTAL | Healthy male and female subjects, non-smoking, will receive multiple doses of ETX2514 1.0 g and sulbactam 1 g via intravenous (IV) infusion every 6 hours with each dose of medication infused over 3 hours. |
| Name | Type | Description |
|---|---|---|
| ETX2514 and sulbactam | DRUG | Each subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours |
Inclusion Criteria: 1. Healthy male or female subject, between 18 and 55 years of age (both inclusive) at the time of screening. 2. Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 and weight between 55.0 and 100.0 kg (both inclusive). 3. Be in general good health without clinically significant ...
ETX2514 is an investigational small molecule being studied for infections caused by Acinetobacter baumannii, including Acinetobacter baumannii-calcoaceticus complex infections. It has been evaluated in healthy subjects to assess safety, tolerability, and pharmacokinetics. The drug is in Phase 1 clinical development and is not yet approved.
ETX2514 is a beta-lactamase inhibitor designed to target and inhibit beta-lactamase enzymes produced by Acinetobacter baumannii. By blocking these enzymes, it aims to restore the activity of beta-lactam antibiotics against resistant bacteria. This mechanism is being investigated in clinical trials for treating Acinetobacter infections.
ETX2514 is being developed by Innoviva, Inc., a company traded on the NASDAQ under the ticker INVA. The drug is currently in Phase 1 clinical trials, with all studies completed. Innoviva is responsible for the clinical development and potential commercialization of this investigational therapy.
ETX2514 is in Phase 1 clinical development. All four clinical trials for the drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval. Its safety, tolerability, and pharmacokinetics have been studied in healthy volunteers.
ETX2514 has completed four Phase 1 clinical trials. These include NCT02971423, a safety and pharmacokinetics study in healthy subjects in Australia; NCT03303924, a study comparing plasma and intrapulmonary concentrations in the US; NCT03985410, a cardiac repolarization study; and NCT04018950, a metabolism and excretion study. All trials are completed.
No, ETX2514 is not the same as sulbactam. ETX2514 is a separate investigational beta-lactamase inhibitor being developed by Innoviva. In clinical trial NCT03303924, ETX2514 was studied in combination with sulbactam to determine their plasma and intrapulmonary concentrations in healthy subjects.