drugset / Trial / NCT03531762

Effect of a Proton Pump Inhibitor on the PK of Tepotinib

NCT03531762

Phase 1 Completed 12 enrolled Merck KGaA, Darmstadt, Germany
RandomizedCrossoverOpen-labelOther

Summary

This study was investigated in healthy participants (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.

Timeline

Start
2018-05-14
Primary completion
2018-07-02
Completion
2018-07-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 40 mg
Subject Tepotinib Small molecule 500 mg Oral

Indications

No indication recorded.