drugset / Trial / NCT06729853
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees of renal function.
Timeline
- Start
- 2024-04-24
- Primary completion
- 2025-01-17
- Completion
- 2025-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAP-001 | Unknown | — | Oral |