Bioequivalence of Tablet Formulation 3 (TF3) and Tablet Formulation 2 (TF2) and Effect of Food on the Pharmacokinetics (PK) of Tepotinib

• Status: Completed
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

Summary

The study will demonstrate bioequivalence between the new tablet formulation (TF3, test treatment) and the tablet formulation used in clinical studies (TF2, reference treatment) and will investigate effect of food on PK of tepotinib.

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

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Tepotinib

Criteria

Inclusion Criteria:

• Healthy participants of non-child bearing potential

• Body weight between 50 to 100 kilogram (kg)

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

• 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