Evaluate Effects of Meropenem-Vaborbactam on QT/QTc in Healthy Volunteers

Exclusion Criteria

• •1. Known hypersensitivity to beta-lactam antibiotics (including meropenem), fluoroquinolone antibiotics (including moxifloxacin) or vaborbactam.
• •2. An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second or third degree atrioventricular block, or any rhythm other than sinus rhythm that is interpreted by the investigator to be clinically significant or one or more of the following: QRS interval \>110 milliseconds (ms); QTcF \>430 ms (males) and \>450 ms (females); PR interval \>200 ms; heart rate (HR) \<50 beats per minutes (bpm); or \>90 bpm.
• •3. History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina. Subjects will also be excluded if there is a family history of long QT syndrome or Brugada syndrome or unexplained sudden death.
• •4. Subject has any clinically relevant abnormalities, as determined by the Investigator, in the laboratory results at Screening or admission of each study period
• •5. Serum potassium, serum magnesium, or albumin-corrected calcium lower than the lower limit of normal for the reference lab at Screening or admission of each study period. Calcium will be corrected for albumin using the formula: Corrected Calcium = (0.8 \* (Normal Albumin - Pt's Albumin)) + Serum Ca where Normal Albumin is 4.0 g/dL.
• •6. Hemoglobin and hematocrit lower than the lower limit of normal for the reference lab at Screening.
• •7. Subject has an abnormal liver function tests: alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or bilirubin greater than 1.2X the upper limits of normal at Screening.
• •8. History of central nervous system (CNS) disorder including convulsions.
• •9. A sustained supine systolic blood pressure \>140 mmHg or \<90 mmHg or a supine diastolic blood pressure \>90 mmHg or \<50 mmHg at Screening or Check in (Day -1). Blood pressure may be retested once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 2 assessments, in which case the subject should not be randomized.
• •10. Impaired renal function as evidenced by estimated glomerular filtration rate (eGFR) \<50.
• •11. Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
• •12. History of acquired immunodeficiency syndrome or history of a positive test result for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B surface antigen (HBsAg) at Screening.
• •13. Positive drug, alcohol, or tobacco screen.
• •14. Clinically-significant illness, including viral syndromes within 3 weeks of dosing.
• •15. Women who are pregnant (or planning to become pregnant within the next 6 months) or currently breastfeeding. A negative serum pregnancy test is required before enrolling in the study.
• •17. Consumed more than 28 units of ethanol per week at any time in the 6 months before dosing (1 unit of ethanol is equivalent to 8 ounces of beer, 4 ounces of wine, or 1 ounce of spirits) or history of alcoholism and/or drug/chemical abuse.
• •18. Use of prescription medications (with the exception of oral contraceptives and hormone replacement therapy), including nonsteroidal anti-inflammatory drugs or sucralfate and medications known to prolong the QT/QTc interval or natural health products/herbal preparations within 14 days or 5 half lives (whichever is longer) before study drug dosing, or use of an over-the-counter (OTC) medication (excluding acetaminophen), vitamins, or supplements (including omega-3 fish oils) within 7 days before study drug dosing.
• •19. Use of alcohol , caffeine , or xanthine containing products, Seville oranges (sour), grapefruit, or grapefruit juice, within 72 hours before study drug dosing.
• •20. Current use or has used tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, etc.) 30 days before study drug dosing.
• •21. Strenuous activity (e.g., sports) from 96 hours (4 days) prior to entry into the clinical research unit and throughout the study (until the final follow-up call is conducted).
• •22. Donated more than 500 milliliter (mL) of blood or significant blood loss within 60 days prior to signing the informed consent form.
• •23. Any other medical, psychological, or social condition that, in the opinion of the principal investigator or the medical monitor, would prevent the subject from fully participating in the study, would represent a concern for study compliance, or would constitute a safety concern to the subject.
• •24. An employee of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as a family member of the employee or investigator.