Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents

Withdrawn before enrolling · Phase 1

Conditions studied: Urinary Tract Infections, Pyelonephritis Acute, Intraabdominal Infections

In brief

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.

Key facts

Study ID

NCT04700787

Run by

Iterum Therapeutics, International Limited

People needed

0

Starts

2021-04-30

Expected to finish

2022-04-04

Last updated by the study team

2022-06-13

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient's parent/both parents or guardian must provide written informed consent and a statement of assent from the adolescent patient (if required by Institutional Review Board [IRB] according to local regulations and guidelines) must be obtained prior to any study-related procedures.
• Patient is male or female adolescent who are ≥12 and <18 years of age.
• Patient has a diagnosis of uUTI, cUTI, AP, or cIAI as documented by the treating physician
• Patient will be hospitalized for urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection for at least 48 hours and be receiving appropriate anti-infective treatment.
• Patient must have sufficient venous access to permit administration of study drug, collection of PK samples, and monitoring of laboratory safety variables.
• Female patients who are post-menarche must not be pregnant or breast feeding and must have a documented negative serum pregnancy test at Screening.
• Post-menarchal females and post-pubertal males must agree to use a highly effective method of birth control with partners of childbearing potential throughout the duration of the study and for 1 month following the last dose of study drug.
• Patient must be willing to follow all study procedures.

You may not qualify if…

• Patient has creatinine clearance <90 mL/min using the Cockcroft-Gault formula.
• Patient is unable to tolerate oral medications.
• Patient has presence of Endocarditis, Meningitis, Necrotizing fasciitis, or Gas gangrene
• Patient has signs of severe sepsis
• Patient has evidence of active liver disease or hepatic dysfunction
• Patient has neutropenia with absolute neutrophil count <500 cells/mm3.
• Patient has history of solid organ transplantation reported at any time.
• Patient has any finding that, in the view of the Investigator, would compromise the patient's safety requirements.
• Patient has known allergies to penicillin, carbapenems, and/or cephalosporins, known allergy to probenecid, or severe allergic reactions to any drug in the past.
• Patient has history of intolerance to β-lactam antibiotics, including but not limited to a history of clinically significant diarrhea/loose stools.
• Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
• Patient has involvement in the planning and/or conduct of this study
• 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.
• Patient has definite or suspected personal history or family history of clinically significant adverse drug reactions.
• 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.
• Patient had treatment in the previous 3 months with any drug known to have a well-defined potential for hepatotoxicity (eg, halothane).
• Patient weighs <35 kg.
• Patient is pregnant or lactating.

Where it is running

• Medical Facility — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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