The study will evaluate the relative bioavailability (rBA) of the intended commercial tablet formulation (Test Treatment, TF2) of Evobrutinib compared to the clinical tablet formulation (Reference Treatment, TF1) of Evobrutinib and to assess the effect of food on the bioavailability of the intended commercial tablet formulation of Evobrutinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A and Treatment B), or under fed conditions that is within 30 minutes after start of high-fat meal (Treatment C) in period 1, 2 and 3.
Nuvisan GmbH
Neu-Ulm, Germany
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib Under Fasted Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fasted Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fasted Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib Under Fed Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fed Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fed Conditions
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity Under Fasted Conditions
Time frame: Day 1 up to Day 6
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings Under Fasted Conditions
Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported
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Time frame: Day 1 up to Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Evobrutinib Administration (AUC0-24)
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Area Under The Plasma Concentration-Time Curve From Time Zero to Time 12 Hours After Evobrutinib Administration (AUC0-12)
Time frame: Pre-dose up to 12 hours post-dose on Day 6
Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Time Prior to the First Measurable (non-zero) Concentration (t lag) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Terminal First Order (elimination) Rate Constant (λz) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Apparent Elimination Half Life (t1/2) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Apparent Total Body Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Day 6
Relative Bioavailability of Test Treatment in Relation to Reference Treatment (Frel)
Time frame: Pre-dose up to 24 hours post-dose on Day 6