drugset / Trial / NCT02457351
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study
NaSingle-groupOpen-label
Summary
To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics of roniciclib in cancer patients. To assess safety and tolerability of roniciclib dosing when administered with and without itraconazole in cancer patients
Timeline
- Start
- 2015-07
- Primary completion
- 2016-02
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | 200 mg | — |
| Subject | Roniciclib | Small molecule | 2.5 mg | Oral |
| Subject | Roniciclib | Small molecule | 5 mg | Oral |
Indications
No indication recorded.