Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

Exclusion Criteria

• •1. Patient has creatinine clearance \<90 mL/min using the Cockcroft-Gault formula.
• •2. Patient is unable to tolerate oral medications.
• •3. Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene
• •4. Patient has signs of severe sepsis
• •5. Patient has evidence of active liver disease or hepatic dysfunction
• •6. Patient has neutropenia with absolute neutrophil count \<500 cells/mm3.
• •7. Patient has history of solid organ transplantation reported at any time.
• •8. Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements.
• •9. Patient has known allergies to penicillin, carbapenems, and/or cephalosporins, known allergy to probenecid, or severe allergic reactions to any drug in the past.
• •10. Patient has history of intolerance to β-lactam antibiotics, including but not limited to a history of clinically significant diarrhea/loose stools.
• •11. Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
• •12. Patient has involvement in the planning and/or conduct of this study
• •13. Patient has participated in any other clinical study where an investigational product was ingested within 30 days or 5 half-lives of the drug (whichever is longer) prior to the current study.
• •14. Patient has definite or suspected personal history or family history of clinically significant adverse drug reactions.
• •15. Patient has history or presence of GI, hepatic, or renal disease, or other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• •16. Patient had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (eg, halothane).
• •17. Patient weighs \<35 kg.
• •18. Patient is pregnant or lactating.