drugset / Trial / NCT05213481
Tepotinib Drug-Drug Interaction Study With Carbamazepine 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 carbamazepine on single- dose tepotinib pharmacokinetics in healthy participants. Study details include: Study Duration: up to about 10 weeks; Treatment Duration: single dose of tepotinib on Days 1 and 26, 25 days of treatment with carbamazepine (Days 8 to 32); Visit Frequency: residence in the Clinical Research Unit from Days -1 to 4 and Days 25 to 29, ambulatory daily visits from Days 5 to 24 and 30 to 33, and one ambulatory visit on Day 39.
Timeline
- Start
- 2021-12-15
- Primary completion
- 2022-05-06
- Completion
- 2022-05-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carbamazepine | Small molecule | 300 mg | Oral |
| Subject | Tepotinib | Small molecule | 500 mg | Oral |
Indications
No indication recorded.