Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CXA-101/tazobactam · 1 trial · 1 indication
The primary endpoint is the baseline-adjusted change in the QTcI between time-matched placebo and study drug.
The primary endpoint is the change from the periodic specific pre-dose baseline of QT/QTcI corrected by QTcI across all dose groups
| Arm | Type | Description |
|---|---|---|
| CXA-101/tazobactam therapeutic dose | EXPERIMENTAL | - |
| CXA-101/tazobactam supra-therapeutic dose | EXPERIMENTAL | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CXA-101/tazobactam | DRUG | 1000/500 mg single IV dose administered over 60 minutes |
| Moxifloxacin | DRUG | 400 mg tablet |
| placebo | DRUG | single IV dose of a saline solution administered over 60 minutes plus oral over-encapsulated moxifloxacin placebo tablet administered at the start of infusion. |
Inclusion Criteria: * Healthy adult male and/or female, 18-45 years of age who can provide written Informed Consent. * Body mass index (BMI) between 18-30, inclusive. * Medically healthy with no clinically significant abnormal screening results (laboratory profiles, medical histories, ECGs, physica...
CXA-101 is an investigational small molecule being studied for complicated urinary tract infections, complicated intra-abdominal infections, and in healthy subjects for safety evaluations. It is in Phase 2 clinical development for the infectious disease therapeutic area.
CXA-101 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in infectious disease indications.
CXA-101 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.
CXA-101 has completed three clinical trials. NCT00921024 studied it in complicated urinary tract infections with 129 participants. NCT01147640 evaluated it in complicated intra-abdominal infections with 122 participants. NCT02508753 assessed its effects on QT/QTc intervals in 52 healthy subjects.
CXA-101 is the base drug, and CXA-101/Tazobactam is a combination formulation that includes tazobactam. Clinical trials have evaluated both the single agent and the combination, with the combination studied in intra-abdominal infections and healthy subjects.