Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
This study is looking at how the bodies of adolescents (ages 12-17) handle a medication called sulopenem etzadroxil plus probenecid. This medication is used to treat bacterial infections. Researchers want to understand if it's safe and well-tolerated in this age group, and how it moves into, through, and out of the body. You would receive a single oral dose of sulopenem etzadroxil plus probenecid in addition to your doctor's usual treatment for your bacterial infection. The study will measure the levels of the medication in your blood and urine over several hours to see how your body processes it. The goal is to learn more about using this drug in adolescents, as it has already been approved for adult women with certain urinary tract infections.
- Study design
- This is an open-label study, meaning you and the researchers will know what medication you are receiving. It plans to enroll 12 adolescent participants.
- What's involved
- You would take a single oral dose of sulopenem etzadroxil plus probenecid. Your blood will be tested for drug levels for 6 hours after the dose, and your urine will be tested for drug levels for 12 hours after the dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your blood and urine will be monitored for drug levels for up to 12 hours after taking the medication.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Senior Vice President and Head of Clinical Development · STUDY_DIRECTOR · Iterum Therapeutics
Who to contact
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What this trial measures
- Sulopenem plasma concentration after dose6 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 dose6 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 dose12 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 dose12 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