Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-03-25 @ 9:07 AM
Study NCT ID:
NCT01744808
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2012-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020
Sponsor:
Neurovance, Inc.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: