NCT03629223

Bioequivalence of TF3 and TF2 and Effect of Food on the PK of Tepotinib

Phase 1, Open-label, 3-Parts Study With Crossover Design in Each Part to Investigate the Bioequivalence of the Tablet Formulation of TF3 Compared to TF2 (Part A), and to Investigate the Influence of Food on the PK of Each TF2 (Part B) and TF3 (Part C) of Tepotinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tepotinib TF2	Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.
DRUG	Tepotinib TF3	Participants received single oral dose of 500 mg (2 x 250 mg)Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.

Timeline

• Start date: 2018-08-23
• Primary completion: 2019-01-25
• Completion: 2019-01-25
• First posted: 2018-08-14
• Last updated: 2023-10-10
• Results posted: 2023-10-10

Locations

1 site across 1 country: Germany