drugset / Trial / NCT05203822
Tepotinib Drug-Drug Interaction Study With Itraconazole in Healthy Participants
Phase 1
Completed
18 enrolled
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
NaSequentialOpen-labelTreatment
Summary
The purpose of this study was to assess the effect of multiple doses of itraconazole on single dose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to 48 days Treatment Duration: single dose of tepotinib on Days 1 and 12, 11 days of treatment with itraconazole (Days 8 to 18) Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 11 to 15, ambulatory daily visits from Days 5 to 10 and 16 to 20
Timeline
- Start
- 2022-01-21
- Primary completion
- 2022-07-05
- Completion
- 2022-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Tepotinib | Small molecule | 500 mg | Oral |
Indications
No indication recorded.