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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01290900 | A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers | PHASE1 | COMPLETED | 54 | — | — | Feb 1, 2011 | May 1, 2011 | Sep 1, 2017 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| CXL104 | EXPERIMENTAL | 2000 mg NXL104 + 1500 mg Ceftaroline (IV) |
| CAZ104 | EXPERIMENTAL | Placebo Infusion (saline) + 2000 mg NXL104 + 3000 mg Ceftazidime (IV) |
| Moxifloxacin | ACTIVE_COMPARATOR | Moxifloxacin 400mg (1 tablet) |
| Placebo | PLACEBO_COMPARATOR | Placebo Infusion (saline) |
| Name | Type | Description |
|---|---|---|
| NXL104 | DRUG | IV Solution |
| Ceftaroline | DRUG | IV Solution |
| Placebo Infusion | DRUG | IV Saline |
| Ceftazidime | DRUG | IV Solution |
| Moxifloxacin | DRUG | Tablet (1) |
Inclusion Criteria: * Provision of signed informed consent prior to any study specific procedures * Healthy male volunteers aged 18 to 45 years (inclusive) with suitable veins for cannulation or repeated venepuncture * Have a body mass index (BMI) between 19 and 30 kg/m2 and a body weight between 6...