drugset / Trial / NCT03021642

Relative Bioavailability of Two Tepotinib Film-Coated Tablet Formulations in Healthy Volunteers

NCT03021642

Phase 1 Completed 24 enrolled Merck KGaA, Darmstadt, Germany
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

EvaluationDrugModalityDoseRoute
Subject Tepotinib Small molecule 500 mg Oral

Indications

No indication recorded.