Last reviewed · How we verify
LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI)
The purpose of the study was to evaluate whether LYS228 can be developed for the treatment of complicated intra-abdominal infections. It was planned that LYS228 exposure across patients with varying renal function would be evaluated during the study to confirm that LYS228 concentrations are predicted to be adequate to treat the patient population. It was planned that the PK exposure of the initial 8 patients would be analyzed. PK analysis was not conducted as per protocol the first analysis required 8 patients.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | PHASE2 |
| Status | TERMINATED |
| Enrolment | 3 |
| Start date | Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Sep 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Intra-abdominal Infections
Interventions
- LYS228
- Standard of care therapy
Countries
United States