Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
brief 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.
detailed 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 pharmacokinetics (PK) of sulopenem etzadroxil plus probenecid in adolescent inpatients and outpatients that are diagnosed with bacterial infections caused by susceptible strains of Gram-positive and Gram-negative bacteria.
The primary objective of the study is to evaluate the PK of oral sulopenem etzadroxil + probenecid in adolescent inpatients and outpatients with bacterial infection. The secondary objective of the study is to evaluate the safety and tolerability of oral sulopenem etzadroxil + probenecid in adolescent inpatients and outpatients with bacterial infection.
The study will be conducted in adolescent inpatients and outpatients who are 12 to 18 years of age and are being treated for bacterial infections caused by susceptible strains (susceptible to penem antibiotics, e.g., imipenem, ertapenem, doripenem, or meropenem, and not resistant to a carbapenem) of Gram-positive and Gram-negative bacteria. Patients who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study. Approximately 12 patients in total will be enrolled.
On Day 1, enrolled patients will receive background antibiotic treatment other than carbapenem antibiotics, per each site's standard of care. Patients will also receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet in the fed state. This dose is the same as the approved dose for treatment of uncomplicated UTI in adult women. During treatment of the underlying bacterial infection, PK samples will be collected, and patients will be monitored for safety and tolerability. A safety follow-up will take place on Day 2 for all patients.
official title
A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection