NCT01744808

A Study to Evaluate the Safety, Tolerance, and Pharmacokinetic and Pharmacodynamic Profile Of 1 SR Formulation of EB-1020

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal, Healthy Volunteers

Interventions

Type	Name	Description
DRUG	EB-1020 IR	Immediate release
DRUG	EB-1020 SR1	sustained release
DRUG	EB-1020 SR2	Sustained release
DRUG	EB-1020 SR3	Sustained release
OTHER	Placebo	Placebo formulation

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-12-07
• Last updated: 2026-04-13

Locations

1 site across 1 country: Australia