Pharmacokinetics After Oral IntakePhase 1NCT07092813
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
A Phase 1 study testing sulopenem etzadroxil and probenecid in people with Pharmacokinetics After Oral Intake, run by Iterum Therapeutics, International Limited at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Pharmacokinetics After Oral Intake
- What is being tested?
- sulopenem etzadroxil and probenecid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- Known renal insufficiency.
- Patient is unable to tolerate oral medications.
- Patient has presence of any of the following conditions:
- Endocarditis
- Meningitis
- Necrotizing fasciitis
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- 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.
- Patient has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures.
- Patient or parent/legal guardian has involvement in the planning and/or conduct of this study (applies to both Iterum Therapeutics staff and/or staff at the study sites).
- 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 (e.g., halothane).
- Patient weighs <30 kg.
- Patient is pregnant or lactating.
- Patient has received a carbapenem as their standard of care therapy to treat the diagnosed bacterial infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical facility
Little Rock, Arkansas, 72205
About this study
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
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.
Read the 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.
- Conditions
- Pharmacokinetics After Oral Intake
- Being tested
- sulopenem etzadroxil and probenecid
- Keywords
- Pharmacokinetics, Adolescents, Sulopenem etzadroxil, Probenecid, Sulopenem, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulopenem etzadroxil and probenecidDrug
Also called Orlynvah
single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.
| Study group | Role | What they receive |
|---|---|---|
| Oral sulopenem | Experimental | Single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. Receives: Drug: sulopenem etzadroxil and probenecid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 hours
Secondary outcomes (1)
Number of participants with treatment emergent adverse events
Safety will be assessed by monitoring adverse events, physical examination, vital signs, and clinical laboratory tests
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startApr 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics After Oral IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iterum Therapeutics, International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Senior Vice President and Head of Clinical Development, Study director, Iterum Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092813
- Sponsor's protocol ID
- IT001-109
- Status last verified
- Mar 2026
- First submitted
- 22 Jul 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pertinent individual participant data sets that underlie results in a publication are to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07092813
- Acronym / sponsor ID
- IT001-109
- Conditions
- Pharmacokinetics After Oral Intake
- Keywords
- Pharmacokinetics, Adolescents, Sulopenem etzadroxil, Probenecid, Sulopenem, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Iterum Therapeutics, International LimitedIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral sulopenem | Experimental | Drug: sulopenem etzadroxil and probenecidSingle dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- Known renal insufficiency.
- Patient is unable to tolerate oral medications.
- Patient has presence of any of the following conditions:
- Patient has signs of severe sepsis including:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulopenem etzadroxil and probenecidAlso: Orlynvahsingle dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. | Drug | Oral sulopenem |
Primary outcome
Sulopenem plasma concentration after dose
Time frame: 6 hours
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Probenecid plasma concentration after dose
Time frame: 6 hours
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Sulopenem urine concentration after dose
Time frame: 12 hours
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
Probenecid urine concentration after dose
Time frame: 12 hours
Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after dose
1 secondary outcome
Number of participants with treatment emergent adverse events
Time frame: 2 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. Pertinent individual participant data sets that underlie results in a publication are to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senior Vice President and Head of Clinical Development study director
Iterum Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sulopenem etzadroxil and probenecid in people with Pharmacokinetics After Oral Intake, run by Iterum Therapeutics, International Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Vice President and Head of Clinical Development (860-661-4035, saronin@iterumtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sulopenem plasma concentration after dose (time frame: 6 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.