Overview
Bioequivalence of 5 Tablets of 100 Milligrams (mg) Versus 2 Tablets of 250 mg Tablet Formulation 3 (TF3) of Tepotinib
Status:
Completed
Completed
Trial end date:
2019-12-16
2019-12-16
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study will investigate the bioequivalence of the 100 mg and 250 mg dose strengths of tepotinib TF3 when administered at the same dose under fasted condition.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyTreatments:
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