At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Tepotinib 100 mg +1 moredrug
Likely dose
Tepotinib 100 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.
An Open-label, Single-dose, Randomized, 2-period, 2-sequence Cross-over, Single-center Phase I Trial in Healthy Subjects to Assess the Bioequivalence of Tepotinib TF3 Administered as 5 Tablets of 100 mg Versus 2 Tablets of 250 mg Dose Strength
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Dec 19, 2019·Updated Nov 8, 2023
In Brief
A Phase 1 clinical trial evaluating Tepotinib 100 mg and Tepotinib 250 mg for Healthy. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under fasted condition.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartOct 2019
Primary CompletionDec 2019
First PostedDec 2019
TodayJul 2026
First PostedDec 19, 2019
Enrollment StartOct 17, 2019
Primary CompletionDec 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.5 years ago
Interventions
Tepotinib 100 mgdrug
Participants received a single oral dose of test treatment of tepotinib TF3 (5 \* 100 mg) in either treatment period 1 or 2.
Tepotinib 250 mgdrug
Participants received a single oral dose of reference treatment of tepotinib TF3 (2 \* 250 mg) in either treatment period 1 or 2.