Trials / Completed
CompletedNCT04546789
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
Phase I Open-label, Single Dose Study to Investigate the Effect of Hepatic Impairment on the PK of Evobrutinib (M2951)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M2951 (BTK inhibitor) | Participants received a single oral dose of M2951 (BTK inhibitor) on Day 1. |
Timeline
- Start date
- 2020-09-30
- Primary completion
- 2021-05-16
- Completion
- 2021-05-16
- First posted
- 2020-09-14
- Last updated
- 2025-10-28
- Results posted
- 2025-10-28
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04546789. Inclusion in this directory is not an endorsement.