CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 66 enrolled
Drug / intervention
Tepotinib TF2 +1 moredrug
Likely dose
Tepotinib TF2 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03629223
NCT03629223Phase 1Completed
CompareCT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Aug 14, 2018·Updated Oct 10, 2023

In Brief

A Phase 1 clinical trial evaluating Tepotinib TF2 and Tepotinib TF3 for Healthy. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartAug 23, 2018
Primary CompletionJan 25, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.9 years ago

Interventions

Tepotinib TF2drug

Participants received a single oral dose of 500 mg Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.

Tepotinib TF3drug

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.