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NCT07092813 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
A Phase 1 study of Pharmacokinetics After Oral Intake, sponsored by Iterum Therapeutics, International Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07092813 is a Phase 1 study of Pharmacokinetics After Oral Intake that is actively recruiting participants, run by Iterum Therapeutics, International Limited. The registered enrollment target is 12 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07092813, a Phase 1 study of Pharmacokinetics After Oral Intake, is actively recruiting participants, sponsored by Iterum Therapeutics, International Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG sulopenem etzadroxil and probenecid
Study Locations (1)
Arkansas
- Medical facility - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-01 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07092813
The ClinicalTrials.gov registry entry for NCT07092813 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iterum Therapeutics, International Limited, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pharmacokinetics After Oral Intake appearing as the primary indexed condition, and to 1 intervention - of which sulopenem etzadroxil and probenecid is the first listed.
NCT07092813 reports 1 study location spanning 1 distinct geographic area - top geographies include Arkansas.
Frequently Asked Questions
What is clinical trial NCT07092813 about?
NCT07092813 is a clinical study titled "Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents". 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 pro...
What is the current status of trial NCT07092813?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-01. Estimated completion is 2026-07.
What conditions does trial NCT07092813 study?
This clinical trial studies the following conditions: Pharmacokinetics After Oral Intake.
What interventions are being tested in trial NCT07092813?
The interventions under investigation include: sulopenem etzadroxil and probenecid (DRUG).
Who is sponsoring clinical trial NCT07092813?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07092813 being conducted?
This trial has 1 study location across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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