Normal, Healthy Volunteers Clinical Trial
Official title:
A Phase 1 Study To Investigate the Pharmacokinetics of SR Formulations; and the Food Effect, Safety, Tolerance, Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020 In Young Healthy Subjects
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.
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label