2-Part Multiple Ascending Dose Study for Safety and Pharmacokinetics in Healthy and Elderly Subjects

Phase 1

Completed

• Conditions: CNS
• Interventions: Drug: Placebo comparator; Drug: E2006

• Registration Number: NCT01673451
• Lead Sponsor: Eisai Inc.

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, sequential, multiple-dose study. The study will be conducted in two parts: Part A (6 cohorts of healthy adults receiving evening dosing) and Part B (one cohort of elderly adults receiving evening dosing).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-21
• Study First Submitted QC: 2012-08-23
• Study First Posted: 2012-08-28
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo comparator	Placebo comparator	-
E2006	E2006	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse events (AEs)	28 days

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of E2006	Part A up to 288 hours postdose; Part B: up to 324 hours postdose

Trial Locations

Locations (1)

Parexel, California Clinical Trials; 🇺🇸 Culver City, California, United States