Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004102-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evobrutinib: Normal Renal Function | Experimental | Subjects with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 90 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) will receive a single oral dose of evobrutinib under fasting conditions. |
|
| Evobrutinib: Severe Renal Impairment | Experimental | Subjects with eGFR less than (<) 30 mL/min/1.73 m^2 will receive a single oral dose of evobrutinib under fasting conditions. |
|
| Evobrutinib: Moderate Renal Impairment | Experimental | Subjects with eGFR >= to 30 mL/min/1.73 m^2 and < 60 mL/min/1.73 m^2 will receive a single oral dose of evobrutinib under fasting conditions. |
|
| Evobrutinib: Mild Renal Impairment | Experimental | Subjects with eGFR >= to 60 mL/min/1.73 m^2 and < 90 mL/min/1.73 m^2 will receive a single oral dose of evobrutinib under fasting conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evobrutinib | Drug | Subjects will be administered a single oral dose of evobrutinib under fasting conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Evobrutinib | Pre-dose up to 30 hours post-dose | |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Evobrutinib | Pre-dose up to 30 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrences of Treatment-emergent Adverse Events (TEAEs) | Day 1 up to Day 6 | |
| Number of Subjects With TEAEs According to Severity | Day 1 up to Day 6 | |
| Number of Subjects With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Please Contact the Merck KGaA Communication Center | Darmstadt | 64293 | Germany |
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| C000632111 | evobrutinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Number of subjects with clinically significant abnormalities will be reported. |
| Day 1 up to Day 6 |
| Time to Reach the Maximum Plasma Concentration (tmax) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Time Prior to the First Measurable (Non-Zero) Concentration (t lag) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Terminal Rate Constant (λz) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Terminal Half-Life (t1/2) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours After Dosing (AUC 0-24h) of Evobrutinib | Pre-dose up to 24 hours post-dose |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours After Dosing (AUC 0-8h) of Evobrutinib | Pre-dose up to 8 hours post-dose |
| Apparent Clearance (CL/f) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib | Pre-dose up to 30 hours post-dose |
| Amount of Unchanged Drug (Evobrutinib) Excreted in Urine During Collection Interval (0-8 hours) (Ae0-8h) | Pre-dose up to 8 hours post-dose |
| Fraction of Administered Drug (Evobrutinib) Excreted in Urine (fe) | Pre-dose up to 30 hours post-dose |
| Fraction of Unbound Drug (Evobrutinib) in the Plasma (fu) | Pre-dose up to 30 hours post-dose |
| Renal Clearance of Evobrutinib (CLR) | Pre-dose up to 30 hours post-dose |
| Non-Renal Clearance of Evobrutinib (CLNonR/f) | Pre-dose up to 30 hours post-dose |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |