Effect of Tepotinib on Pharmacokinetics (PK) of Cytochrome P450 (CYP) 3A Substrate Midazolam

• Status: Completed
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The study will investigate the effect of tepotinib on the PK of the CYP3A substrate midazolam determined from concentrations of midazolam and its main metabolite 1-hydroxymidazolam in healthy participants.

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

Details

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