NCT03531762

Effect of a Proton Pump Inhibitor on the PK of Tepotinib

Phase I, Open-label, Three-Period Crossover Study to Investigate the Effect of a Proton Pump Inhibitor (Omeprazole) on the PK of Tepotinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tepotinib	Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.
DRUG	Omeprazole	Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.

Timeline

• Start date: 2018-05-14
• Primary completion: 2018-07-02
• Completion: 2018-07-02
• First posted: 2018-05-22
• Last updated: 2023-07-28
• Results posted: 2023-07-28

Locations

1 site across 1 country: Germany