This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour prior to start of a low-fat meal, and 2 hours after start of a low-fat meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D).
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
Time frame: Pre-dose up to 24 hours post-dose
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Maximum Plasma Concentration Observed (Cmax) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Number of Participants With Treatment -Emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Day 9
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings
Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported
Time frame: Day 1 up to Day 9
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Drug Administration (AUC0-24) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Area Under The Concentration-Time Curve from Time Zero to Time 12 Hours (AUC0-12) of Evobrutinib
Time frame: Pre-dose up to 12 Hours post-dose
Time to Reach Maximum Concentration (Tmax) of Evobrutinib in Plasma
Time frame: Pre-dose up to 24 hours post-dose
Time Prior to the First Measurable (non-zero) Concentration of Evobrutinib
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Time frame: Pre-dose up to 24 hours post-dose
Apparent Elimination Half Life (t1/2) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Apparent Clearance (CL/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose
Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose