NCT01673451

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

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of E2006 in Healthy Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• CNS

Interventions

Type	Name	Description
DRUG	E2006	Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules
DRUG	Placebo comparator	E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2012-08-28
• Last updated: 2013-10-11

Locations

2 sites across 1 country: United States