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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: Recruiting Phase 1 study of Pharmacokinetics After Oral Intake, sponsored by Iterum Therapeutics, International Limited.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
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 |
What NCT07092813 shows while recruiting
NCT07092813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07092813's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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