Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07092813 | Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents | PHASE1 | RECRUITING | 12 | — | — | Apr 1, 2026 | Oct 1, 2026 | Mar 27, 2026 | 1 | United States |
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the dose
Concentrations will be determined through analysis of blood samples drawn at 1, 2, 4 and 6 hours after the 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
Concentrations will be determined through analysis of urine samples collected 0-2, 2-4, 4-6, 6-8 and 8-12 hours after dose
| Arm | Type | Description |
|---|---|---|
| Oral sulopenem | EXPERIMENTAL | Single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. |
| Name | Type | Description |
|---|---|---|
| sulopenem etzadroxil and probenecid | DRUG | single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet. |
Inclusion Criteria: 1. 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 ...