Urinary Tract InfectionsPhase 1NCT04700787
Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
A Phase 1 study testing Sulopenem in people with Urinary Tract Infections and Pyelonephritis Acute, run by Iterum Therapeutics, International Limited at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Urinary Tract Infections, Pyelonephritis Acute, Intraabdominal Infections
- What is being tested?
- Sulopenem
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 4 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem and Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Hospitalized patients who are 12-18 years of age and who are receiving background antibiotic treatment for uncomplicated urinary tract infection, complicated urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection, and who meet eligibility requirements will receive a single 1000 mg IV dose of sulopenem on Day 1. The following day, patients will receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. During treatment, pharmacokinetic samples will be collected and patients will be monitored for safety and tolerability.
- Being tested
- Sulopenem
- Medical subject headings
- Urinary Tract Infections, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulopenemDrug
sulopenem intravenous 1000 mg on Day 1 and then sulopenem etzadroxil/probenecid oral 500 mg/500 mg on Day 2
| Study group | Role | What they receive |
|---|---|---|
| Sulopenem | Experimental | Sulopenem intravenous 1000 mg (single dose) on Day 1 followed by oral sulopenem etzadroxil/probenecid 500 mg/500 mg (single dose) on Day 2. Receives: Drug: Sulopenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration
Maximum plasma concentration (Cmax) of sulopenem at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Secondary outcomes (10)
Time to maximum plasma concentration
Time to maximum plasma concentration (Tmax) of sulopenem at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Time above minimum inhibitory concentration
Time above minimum inhibitory concentration (MIC) at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable plasma concentration at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Area under the plasma concentration-time curve (AUC) from time zero extrapolated to infinity at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Percentage of area under the concentration-time curve extrapolated
Percentage of area under the concentration-time curve (AUC) extrapolated at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Terminal elimination half-life
Terminal elimination half-life at multiple timepoints after dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Total body clearance for intravenous administration
Total body clearance for intravenous administration at multiple timepoints after intravenous dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Apparent total body clearance for oral administration
Apparent total body clearance for oral administration at multiple timepoints after oral dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Volume of distribution for intravenous administration
Volume of distribution for intravenous administration at multiple timepoints after intravenous dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Apparent volume of distribution for oral administration
Apparent volume of distribution for oral administration at multiple timepoints after oral dose
Measured: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start30 Apr 2021
- Primary completion25 Mar 2022
- Study completion4 Apr 2022
Why it stopped: Enrollment challenges and change in development plan necessitating a change in study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iterum Therapeutics, International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven I Aronin, MD, Study director, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700787
- Sponsor's protocol ID
- IT001-106
- Status last verified
- Jun 2022
- First submitted
- 6 Jan 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. 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 and Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection
- ClinicalTrials.gov ID
- NCT04700787
- Acronym / sponsor ID
- IT001-106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment challenges and change in development plan necessitating a change in study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iterum Therapeutics, International LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 8 Jan 2021 (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 purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous sulopenem and oral sulopenem etzadroxil/probenecid in adolescent patients.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility. Hospitalized patients who are 12-18 years of age and who are receiving background antibiotic treatment for uncomplicated urinary tract infection, complicated urinary tract infection, acute pyelonephritis, or complicated intraabdominal infection, and who meet eligibility requirements will receive a single 1000 mg IV dose of sulopenem on Day 1. The following day, patients will receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. During treatment, pharmacokinetic samples will be collected and patients will be monitored for safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulopenem | Experimental | Drug: SulopenemSulopenem intravenous 1000 mg (single dose) on Day 1 followed by oral sulopenem etzadroxil/probenecid 500 mg/500 mg (single dose) on Day 2. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 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.
- 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.
Key exclusion criteria (18 listed)
- 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
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 |
|---|---|---|
| Sulopenemsulopenem intravenous 1000 mg on Day 1 and then sulopenem etzadroxil/probenecid oral 500 mg/500 mg on Day 2 | Drug | Sulopenem |
Primary outcome
Maximum plasma concentration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Maximum plasma concentration (Cmax) of sulopenem at multiple timepoints after dose
10 secondary outcomes
Time to maximum plasma concentration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Time above minimum inhibitory concentration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Percentage of area under the concentration-time curve extrapolated
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Terminal elimination half-life
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Total body clearance for intravenous administration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Apparent total body clearance for oral administration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Volume of distribution for intravenous administration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Apparent volume of distribution for oral administration
Time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Steven I Aronin, MD study director
Employee
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 in people with Urinary Tract Infections and Pyelonephritis Acute, 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 8 inclusion and 18 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: withdrawn, as of the sponsor's last update on 13 Jun 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (time frame: To be measured at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 9.0, 10.0, and 12.0 hours post dose). 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 13 Jun 2022.