A Single-Dose, Randomized, Placebo- and Active-Control, Four-Way, Cross-Over Study for the Evaluation of the Effect of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) on the QT/QTc Intervals in Adult Healthy Subjects

Subjects must not be enrolled in the study if they meet any of the following criteria:

1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.

2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

3. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

4. History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.

5. History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).

6. History or presence of any of the following, deemed clinically significant by the PI or designee:

1. Ventricular pre-excitation syndrome (Wolff-Parkinson White syndrome);

2. Arrhythmia or history of arrhythmia requiring medical intervention;

3. Risk factors for Torsade de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome);

4. Sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities.

7. Allergy to ECG electrode adhesive patches, band aids, adhesive dressing or medical tape.

8. History of epilepsy or seizure disorder.

9. History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia).

10. Female subjects with a positive pregnancy test or who are lactating.

11. Positive urine drug or alcohol results at screening or first check-in.

12. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

13. Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening.

14. Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening.

15. Estimated creatinine clearance \<80 mL/min at screening.

16. Unable to refrain from or anticipates the use of the following drugs beginning 14 days prior to the first dosing and throughout the study:

* Any drug, including prescription and non-prescription medications , herbal remedies, or vitamin supplements. After first dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the PI or designee.

* Any gastric acid-reducing medications, including but not limited to proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole), histamine-2 receptor antagonists (e.g., nizatidine, famotidine, cimetidine, ranitidine), and antacids (e.g., Alka-Seltzer, Milk of Magnesia, Amphojel, Gelusil, Maalox, Mylanta, Rolaids, Pepto-Bismol).

* Valproic acid or divalproex sodium.

* Probenecid.

17. Has been on a diet incompatible with the on-study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing and throughout the study.

18. Donation of blood or significant blood loss within 56 days prior to the first dosing.

19. Plasma donation within 7 days prior to the first dosing.

20. Participation in another clinical study within 30 days prior to the first dosing. The 30- day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.

What this study is about