Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WCK 5222 | Experimental | WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion) |
|
| Placebo (IV placebo matched toWCK 5222IV solution) | Placebo Comparator | placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution |
|
| Moxifloxacin 400-mg | Active Comparator | positive control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WCK 5222 | Drug | FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delay in cardiac repolarization induced by WCK 5222 | as shown by analysis of the QT interval. | 0-4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation | Tolerability will be assessed by review of number of AEs | 0-4 days |
| Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research | West Bend | Wisconsin | 53095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000624485 | cefepime-zidebactam |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IV placebo matched to WCK 5222 / Moxifloxacin IV solution |
| Drug |
Placebo (IV placebo matched to FEP-ZID IV solution) and 1 placebo capsule matched to moxifloxacin overencapsulated tablet |
|
|
| Moxifloxacin 400-mg | Drug | Moxifloxacin 400-mg positive control (overencapsulated tablet) |
|
Safety will be assessed by review of adverse events (AEs), ECGs, and clinical laboratory safety test results |
| 0-4 days |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |