drugset / Trial / NCT05084651
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Itraconazole
NaSequentialOpen-labelTreatment
Summary
The study will assess the effect of multiple doses of itraconazole, a strong CYP3A4/5 inhibitor, on the PK of ganaplacide and lumefantrine in healthy participants. This study will provide data that is relevant for advice regarding possible concomitant medications that are inhibitors of CYP3A4/5 in future clinical studies with ganaplacide and lumefantrine and for potential future labeling considerations
Timeline
- Start
- 2021-11-18
- Primary completion
- 2022-05-13
- Completion
- 2022-05-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ganaplacide | Small molecule | 400 mg | Oral |
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | lumefantrine | Small molecule | 480 mg | Oral |