Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01744808
Brief Summary:
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.
Detailed Description:
* 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:
NCT01744808
Study Brief:
Protocol Section:
NCT01744808