drugset / Trial / NCT05412472
Study to Evaluate the Effects of Renal Impairment on the Pharmacokinetics, Safety and Tolerability of GC4419
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The study is a two-center, Phase 1, open-label, single-dose, one-period, four groups, PK study in subjects with various severities of renal impairment and matched healthy controls.
Timeline
- Start
- 2019-04-04
- Primary completion
- 2021-01-30
- Completion
- 2021-04-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avasopasem manganese | Other / unclassified | 45 mg | Intravenous |