drugset / Trial / NCT05926180
Assessing the Effect of DZD9008 on the Pharmacokinetics of the Cocktail Probes Representative for CYP3A4, P-gp, BCRP and OATP1B1 in Patients with EGFR or HER2 Mutant Advanced Non-small Cell Lung Cancer (WU-KONG19)
NaSingle-groupOpen-labelTreatment
Summary
This study will treat patients with advanced NSCLC who have progressed following prior therapy in order to assess the effect of DZD9008 on exposure of midazolam, digoxin and rosuvastatin, through multiple PK parameters, when administrated as a single dose alone and in combination with DZD9008. Also, it will assess the safety and tolerability of DZD9008 in the presence and absence of co-administration of cocktail probes.
Timeline
- Start
- 2023-07-31
- Primary completion
- 2024-05-16
- Completion
- 2024-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Digoxin | Other / unclassified | 0.25 mg | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | Sunvozertinib | Small molecule | 300 mg | Oral |