To investigate whether there is a food-effect with oral administration with EB-1020 as well as to obtain information on the safety, and tolerability of EB-1020 in a range of doses.
* To investigate the safety and tolerance of single doses of EB-1020 immediate release (IR) versus three sustained release (SR) formulations. * To investigate the safety and tolerance of a single oral dose of a SR formulation of EB-1020 in the fed and fasted state. * To investigate the safety, tolerance, and cognitive effects of multiple oral rising doses of a SR formulation of EB-1020. Secondary Objectives * To characterize the single dose and steady state pharmacokinetic profiles of EB-1020 SR formulations. * To investigate the effect of food on the pharmacokinetic profile of EB-1020 SR following single oral doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
54
Nucleus Network Ltd.
Melbourne, Victoria, Australia
Cmax
Pharmacokinetic parameters
Time frame: up to 6 months
Tmax
Pharmacokinetic parameter
Time frame: up to 6 months
AUC
Pharmacokinetic parameter
Time frame: up to 6 months
Effect of food on Cmax
Time frame: up to 6 months
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Sustained release
Placebo formulation