At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
Tepotinibdrug
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.
Open-Label, Parallel-Group Phase 1 Study to Investigate the Effect of Various Degrees of Hepatic Impairment on the PK, Safety and Tolerability of the c-Met Kinase Inhibitor Tepotinib
EMD Serono Research & Development Institute, Inc.·interventional·Posted Jun 6, 2018·Updated Aug 12, 2024
In Brief
A Phase 1 clinical trial evaluating Tepotinib for Hepatic Impairment. Completed, enrolled 18 participants across 2 sites.
Detailed Summary
The study investigated the effect of various degrees of hepatic impairment on the pharmacokinetics (PK), safety and tolerability of tepotinib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesUnited States
CollaboratorsMerck KGaA, Darmstadt, Germany
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartJun 2018
Primary CompletionFeb 2019
TodayJul 2026
First PostedJun 6, 2018
Enrollment StartJun 13, 2018
Primary CompletionFeb 5, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.1 years ago
Interventions
Tepotinibdrug
Participants received a single oral dose of tepotinib in Part 1.