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| ID | Type | Description | Link |
|---|---|---|---|
| CXA-QT-10-02 | Other Identifier | Cubist Protocol Number |
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The purpose of the study is look at the possible side effects of two different doses of CXA-101/tazobactam, a low dose and a high dose, on participant's heart.
Some drugs can have effects on the cardiovascular system (hearts and blood vessels) including the QT interval. The QT interval is the time between the contraction and relaxation of the chambers of the heart, called ventricles, which collect and pump blood. The use of some drugs can lead to serious issues such as QT interval prolongation (lengthen) and potentially serious arrhythmias (abnormal heart beat), and sudden death. Therefore, it is important to study effect of medications on the heart.
The drug, Moxifloxacin, will be introduced as a control to be able to compare the effect, if any, that CXA 101/tazobactam might have on participant's heart.Moxifloxacin is an approved antibiotic commonly used to treat common bacterial infections. Moxifloxacin is known to slightly increase the electrical conduction of participant's heart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXA-101/tazobactam therapeutic dose | Experimental |
| |
| CXA-101/tazobactam supra-therapeutic dose | Experimental |
| |
| Moxifloxacin | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CXA-101/tazobactam | Drug | 1000/500 mg single IV dose administered over 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change from the pre-dose baseline in the individual subject (subject-specific) correction, QTcI. | The primary endpoint is the baseline-adjusted change in the QTcI between time-matched placebo and study drug. | Baseline through Day 13 |
| The change from the periodic specific pre-dose baseline of QT/QTcI | The primary endpoint is the change from the periodic specific pre-dose baseline of QT/QTcI corrected by QTcI across all dose groups | Baseline through Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| The change from pre-dose baseline in the QT/QTcI corrected by QTcB and QTcF interval. | Baseline through Day 13 | |
| Characterize concentration-response relationship for QT/QTcI | Baseline through Day 13 |
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Inclusion Criteria:
Consistent sinus rhythm No clinically significant conduction disorders PR interval between 120 and 210 milliseconds (msec), inclusive Heart rate (HR) greater than or equal to 50 beats per minute (bpm) and less than or equal to 100 bpm QRS interval less than or equal to 110 msec QT intervals that can be consistently analyzed (T wave amplitude 2 mm or greater, lack of artifact [noise] and excessive baseline wandering, without any form of bundle branch block).
QTcF interval less than or equal to 430 msec for males and less than or equal to 450 msec for females.
Calculated creatinine clearance >80 mL/min. at screening using the Cockcroft-Gault formula.
If female, subject must have a negative serum pregnancy test at screening and agrees to either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study, or use one of the following acceptable birth control methods:
If male, subject agrees to use a medically acceptable contraceptive defined as:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cetero Reserach | Fargo | North Dakota | 58104 | United States |
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| CXA-101/tazobactam | Drug | 3000/1500 mg single IV dose administered over 60 minutes |
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| Moxifloxacin | Drug | 400 mg tablet |
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| 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. |
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| Provide safety information by the collection of adverse events | Collect AEs | Baseline through Day 21 |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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