Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents

NCT07092813 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IT001-109
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics After Oral Intake

Keywords

Pharmacokinetics; Adolescents; Sulopenem etzadroxil; Probenecid; Sulopenem; Phase 1

Outcome Measures

Primary Outcomes (4)

• Sulopenem plasma concentration after dose

  Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose

  6 hours

• Probenecid plasma concentration after dose

  Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose

  6 hours

• Sulopenem urine concentration after dose

  Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after the dose

  12 hours

• Probenecid urine concentration after dose

  Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after dose

  12 hours

Secondary Outcomes (1)

• Number of participants with treatment emergent adverse events

  2 days

Study Arms (1)

Oral sulopenem

EXPERIMENTAL

Single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.

Drug: sulopenem etzadroxil and probenecid

Interventions

sulopenem etzadroxil and probenecid DRUG

single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.

Also known as: Orlynvah

Oral sulopenem

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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. Communication should take place between the Investigator, parent(s)/guardian, and adolescent patient to confirm understanding and compliance with the study requirements.
• Patient is male or female adolescent who are more than or equal to 12 and \<18 years of age.
• Patient has a diagnosis of a bacterial infection as documented by the treating physician
• Patient will be receiving appropriate anti-infective treatment for a bacterial infection.
• Patient must have sufficient venous access to permit collection of PK samples and monitoring of laboratory safety variables.
• Female patients who are postmenarchal must not be pregnant, or breast feeding and must have a documented negative pregnancy test at Screening.
• Postmenarchal 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.
• NOTE: A highly effective method of birth control is defined as one that results in a low failure rate (i.e., \<1% per year) when used consistently and correctly. This includes sexual abstinence, implants, some intrauterine devices, or a vasectomized partner. A vasectomy or a condom used with a spermicide is a medically acceptable form of birth control for males.
• Patient must be willing to follow all study procedures.

You may not qualify if:

• Known renal insufficiency.
• Patient is unable to tolerate oral medications.
• Patient has presence of any of the following conditions:
• Endocarditis
• Meningitis
• Necrotizing fasciitis
• Gas gangrene
• Patient has signs of severe sepsis including:
• Shock or profound hypotension that is not responsive to fluid challenge.
• Disseminated intravascular coagulation as evidenced by prothrombin time or partial thromboplastin time more than or equal to 2 × the upper limit of normal (ULN) or platelets \<50% of the lower limit of the normal.
• Patient has known active liver disease or hepatic dysfunction (except a confirmed diagnosis of Gilbert's disease) defined as non-transient elevations of aspartate aminotransferase or alanine aminotransferase level elevations more than or equal to 3 × the ULN or non-transient total bilirubin more than or equal to 2 × the ULN.
• Known neutropenia (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 cephalosporin antibiotics, known allergy to probenecid, or severe allergic reactions to any drug in the past.

Sponsors & Collaborators

• Iterum Therapeutics, International Limited: lead

Study Sites (1)

Medical facility

Little Rock, Arkansas, 72205, United States

RECRUITING

MeSH Terms

Interventions

Probenecid

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Senior Vice President and Head of Clinical Development

  Iterum Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Senior Vice President and Head of Clinical Development

CONTACT

860-661-4035; saronin@iterumtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Approximately July 2026 - July 2027
• Access Criteria: Following completion of the study, the data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential. The Investigator must consult with the Sponsor before any study data are submitted for publication. The Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved

Locations

US (1)