CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
Tepotinib +1 moredrug
Likely dose
Tepotinib 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/NCT03531762
NCT03531762Phase 1Completed
CompareCT.gov

Phase I, Open-label, Three-Period Crossover Study to Investigate the Effect of a Proton Pump Inhibitor (Omeprazole) on the PK of Tepotinib in Healthy Subjects

Merck KGaA, Darmstadt, Germany·interventional·Posted May 22, 2018·Updated Jul 28, 2023

In Brief

A Phase 1 clinical trial evaluating Tepotinib and Omeprazole for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

This study was investigated in healthy participants (i) the effect of omeprazole (proton pump inhibitor) co-administration on the single dose pharmacokinetics (PK) of tepotinib under fed conditions, and (ii) the effect of food on the single dose PK of tepotinib after co-administration of omeprazole and tepotinib. Furthermore, the study assessed the safety and tolerability of tepotinib alone and upon co-administration of omeprazole.

Study Details

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

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 22, 2018
Enrollment StartMay 14, 2018
Primary CompletionJul 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.1 years ago

Interventions

Tepotinibdrug

Participants received single oral dose of 500 mg Tepotinib in Treatment A, B and C.

Omeprazoledrug

Participants received omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment B and C.