drugset / Trial / NCT03021642
Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers
RandomizedCrossoverOpen-labelTreatment
Summary
This is a Phase I, open label, randomized, crossover trial to investigate the relative bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference, test. The reference treatment refers to the current Phase II film-coated tablet (5 \* 100 milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III film-coated tablet (1 \* 500 mg film-coated tepotinib tablet).
Timeline
- Start
- 2016-01-31
- Primary completion
- 2016-03-31
- Completion
- 2016-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tepotinib | Small molecule | 500 mg | Oral |
Indications
No indication recorded.