drugset / Trial / NCT04486625
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Non-randomizedParallel-groupOpen-labelOther
Summary
This Phase 1 study is being conducted to evaluate the effect of severe renal impairment on the PK, safety and tolerability of Aztreonam-Avibactam. Results from this study along with previous renal impairment data from each of the Aztreonam-Avibactam components will be used to confirm the proposed dosing adjustment in severe renal impairment which was based on modelling/simulation.
Timeline
- Start
- 2020-08-10
- Primary completion
- 2021-09-20
- Completion
- 2021-10-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aztreonam | Small molecule | 675 mg | Intravenous |
| Subject | Aztreonam | Small molecule | 1500 mg | Intravenous |
| Subject | avibactam | Small molecule | 225 mg | Intravenous |
| Subject | avibactam | Small molecule | 500 mg | Intravenous |