At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Dabigatran Etexilate +1 moredrug
Likely dose
Not stated in 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.
Phase I, Open-label, Single Sequence, Two-Period Study to Evaluate the Effect of Tepotinib on P-gp by Investigating the PK of the P-gp Probe Substrate Dabigatran Etexilate in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Dabigatran Etexilate and Tepotinib for Healthy. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This study investigated the effect of Tepotinib on the pharmacokinetics (PK) of the p-glycoprotein (P-gp) probe substrate Dabigatran etexilate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedApr 2018
Enrollment StartMay 2018
Primary CompletionAug 2018
TodayJul 2026
First PostedApr 10, 2018
Enrollment StartMay 17, 2018
Primary CompletionAug 27, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.2 years ago
Interventions
Dabigatran Etexilatedrug
Participants received single oral dose of Dabigatran etexilate on Day 1 of Treatment period 1 and co-administration of Dabigatran with Tepotinib on Day 8 of Treatment period 2.
Tepotinibdrug
Participants received single oral dose of Tepotinib for 8 days in Treatment period 2.