Effect of a Proton Pump Inhibitor on the Pharmacokinetics (PK) of Tepotinib

• Status: Completed
• Trial end date: 2018-07-02
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate in healthy subjects (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose 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 will assess the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Omeprazole; Proton Pump Inhibitors; Tepotinib

Criteria

Inclusion Criteria:

• Healthy participants of non-child bearing potential

• Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

• Body weight between 50 to 100 kilogram (kg)

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Participation in a clinical study within 60 days prior to first drug administration

• Whole blood donation or loss of greater than (>) 450 milliliter (mL) within 60 days prior to first drug administration

• Any surgical or medical condition, or any other significant disease that could interfere with the study objectives, conduct, or evaluation

• Other protocol defined exclusion criteria could apply