drugset / Trial / NCT06504862
A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood
Non-randomizedCrossoverOpen-labelTreatment
Summary
For Part 1 of the trial, the main objective is to assess the effect of a single dose of zongertinib on the pharmacokinetics of a single dose of dabigatran-etexilate. For Part 2 of the trial, the main objective is to assess the effect of zongertinib at steady-state on the pharmacokinetics of a single dose of rosuvastatin, metformin and furosemide (administered as a cocktail).
Timeline
- Start
- 2024-08-20
- Primary completion
- 2024-10-03
- Completion
- 2024-12-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dabigatran etexilate | Unknown | 150 mg | Oral |
| Subject | Furosemide | Other / unclassified | 1 mg | Oral |
| Subject | Metformin | Small molecule | 10 mg | Oral |
| Subject | Rosuvastatin | Small molecule | 10 mg | Oral |
| Subject | Zongertinib | Small molecule | 120 mg | Oral |
Indications
No indication recorded.