drugset / Trial / NCT04455100
A Phase I Study of SHR1459 in Healthy Subjects
Phase 1
Completed
20 enrolled
Jiangsu HengRui Medicine Co., Ltd.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · collab
NaSingle-groupOpen-labelOther
Summary
Following a 10-hour overnight fast, subjects will be administered one dose of SHR1459 orally with 240 mL of ambient temperature water on Day 1. D2-D3 was the cleaning period. Itraconazole will be administered orally 200 mg/time/day form D4 to D8 after meal. On D7 following a 10-hour overnight fast, subjects will be administered SHR1459 and itraconazole 200 mg with 240 mL of ambient temperature water.
Timeline
- Start
- 2020-07-17
- Primary completion
- 2020-08-14
- Completion
- 2020-08-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EDRALBRUTINIB | Small molecule | — | Oral |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
Indications
No indication recorded.