A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection
Iterum Therapeutics, International Limited
Summary
The goal of this clinical trial is to evaluate the use of sulopenem etzadroxil plus probenecid in adolescent patients being treated for bacterial infection. The main questions it aims to answer are: Is sulopenem etzadroxil plus probenecid safe to use in adolescents? Is sulopenem etzadroxil plus probenecid tolerable when used in adolescents? When ingested, what does the adolescent body do to sulopenem etzadroxil plus probenecid, in terms of the movement of the drug into, through, and out of the body. Participants will receive standard of care antibiotics for their bacterial infection as directed by their physician. In addition, participants will be asked to take a single oral dose of sulopenem etzadroxil plus probenecid. Blood samples will be collected before the dose of sulopenem etzadroxil plus probenecid, as well as at specified timepoints after the dose. Likewise, urine will be collected at specified time periods after the dose. During the course of the study, data will be collected from participants including vital sign measurements, physical examination findings, and the details of any adverse events that are reported.
Description
Sulopenem is a broad-spectrum penem β-lactam antibiotic that is being developed for the treatment of infections with common hospital and community pathogens. The intravenous (IV) formulation is intended for the initial treatment of infections in a hospital setting. ORLYNVAH (sulopenem etzadroxil and probenecid) oral tablets was approved by the FDA for the treatment of adult women with uncomplicated urinary tract infection (UTI) in October 2024. ORLYNVAH has not been studied in the pediatric population. This is a Phase 1, multi-center, open-label study to evaluate the safety, tolerability, and…
Eligibility
- Age range
- 12–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 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. Communication should take place between the Investigator, parent(s)/guardian, and adolescent patient to confirm understanding and compliance with the study requirements. 2. Patient is male or female adolescent who are more than or equal to 12 and \<18 years of age. 3. Patient has a diagn…
Interventions
- Drugsulopenem etzadroxil and probenecid
single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.
Location
- Medical facilityLittle Rock, Arkansas