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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
31
Subjects will be administered a single oral dose of evobrutinib under fasting conditions.
Please Contact the Merck KGaA Communication Center
Darmstadt, Germany
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC 0-t) of Evobrutinib
Time frame: 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
Time frame: Pre-dose up to 30 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
Time frame: Pre-dose up to 30 hours post-dose
Occurrences of Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 6
Number of Subjects With TEAEs According to Severity
Time frame: Day 1 up to Day 6
Number of Subjects With Clinically Significant Abnormalities in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings
Number of subjects with clinically significant abnormalities will be reported.
Time frame: Day 1 up to Day 6
Time to Reach the Maximum Plasma Concentration (tmax) of Evobrutinib
Time frame: Pre-dose up to 30 hours post-dose
Time Prior to the First Measurable (Non-Zero) Concentration (t lag) of Evobrutinib
Time frame: Pre-dose up to 30 hours post-dose
Terminal Rate Constant (λz) of Evobrutinib
Time frame: Pre-dose up to 30 hours post-dose
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Terminal Half-Life (t1/2) of Evobrutinib
Time frame: 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
Time frame: 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
Time frame: Pre-dose up to 8 hours post-dose
Apparent Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to 30 hours post-dose
Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib
Time frame: Pre-dose up to 30 hours post-dose
Amount of Unchanged Drug (Evobrutinib) Excreted in Urine During Collection Interval (0-8 hours) (Ae0-8h)
Time frame: Pre-dose up to 8 hours post-dose
Fraction of Administered Drug (Evobrutinib) Excreted in Urine (fe)
Time frame: Pre-dose up to 30 hours post-dose
Fraction of Unbound Drug (Evobrutinib) in the Plasma (fu)
Time frame: Pre-dose up to 30 hours post-dose
Renal Clearance of Evobrutinib (CLR)
Time frame: Pre-dose up to 30 hours post-dose
Non-Renal Clearance of Evobrutinib (CLNonR/f)
Time frame: Pre-dose up to 30 hours post-dose