drugset / Trial / NCT03310463
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This research project is being conducted to look at the pharmacokinetics (PK; how the human body processes a substance), safety, and tolerability of a single dose of ETX2514 and sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion in participants with various degrees of renal impairment (RI), in participants with end-stage renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control participants with normal renal function.
Timeline
- Start
- 2017-10-03
- Primary completion
- 2018-05-25
- Completion
- 2018-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durlobactam | Small molecule | 1000 mg | Intravenous |
| Subject | Sulbactam | Small molecule | 1000 mg | Intravenous |