Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02508753 | Safety Study Designed to Study the Effects of Two Different Doses of CXA-101/Tazobactam, a Low Dose and a High Dose, on the QT/QTc Intervals in Healthy Subjects | PHASE1 | COMPLETED | 52 | — | — | Jun 1, 2010 | Jul 1, 2010 | Jan 26, 2017 | 1 | United States |
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...