At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
M2951 (BTK inhibitor)drug
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 Dose Study to Investigate the Effect of Hepatic Impairment on the PK of Evobrutinib (M2951)
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany·interventional·Posted Sep 14, 2020·Updated Oct 28, 2025
In Brief
A Phase 1 clinical trial evaluating M2951 (BTK inhibitor) for Hepatic Impairment. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This study was to investigate the pharmacokinetic (PK) and safety of M2951 (Bruton's tyrosine kinase \[BTK\] inhibitor) in participants with different degrees of hepatic impairment compared to participants with normal hepatic function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesGermany
Collaborators--
Timeline
Phase 1CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartSep 2020
Primary CompletionMay 2021
TodayJul 2026
First PostedSep 14, 2020
Enrollment StartSep 30, 2020
Primary CompletionMay 16, 2021
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 5.8 years ago
Interventions
M2951 (BTK inhibitor)drug
Participants received a single oral dose of M2951 (BTK inhibitor) on Day 1.