Trials / Completed
CompletedNCT03436394
Effect of Renal Impairment on Evobrutinib Pharmacokinetics (PK)
Phase I, Open-label, Single Dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics (PK) of Evobrutinib (M2951) Compared to Normal Renal Function in Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Accepted
Summary
The study will investigate the PK and safety of evobrutinib in subjects with different degree of renal impairment as compared to subjects with normal renal function.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Evobrutinib | Subjects will be administered a single oral dose of evobrutinib under fasting conditions. |
Timeline
- Start date
- 2018-03-21
- Primary completion
- 2019-02-22
- Completion
- 2019-02-22
- First posted
- 2018-02-19
- Last updated
- 2019-05-16
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03436394. Inclusion in this directory is not an endorsement.