drugset / Trial / NCT04700787
Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-04-30
- Primary completion
- 2022-03-25
- Completion
- 2022-04-04
Outcome
Outcome not reported
Stopped (Enrollment): “Enrollment challenges and change in development plan necessitating a change in study design”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Probenecid | Small molecule | 500 mg | Oral |
| Subject | Sulopenem | Small molecule | 1000 mg | Intravenous |
| Subject | sulopenem etzadroxil | Small molecule | 500 mg | Oral |