NCT01221259

Brief Summary

This study is designed as a single ascending dose study in healthy subjects to evaluate safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) in plasma and Cerebrospinal (CSF) following single oral doses of E2212.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 22, 2013

Status Verified

February 1, 2013

Enrollment Period

1.7 years

First QC Date

October 13, 2010

Last Update Submit

May 20, 2013

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.

    21 days

Study Arms (2)

Drug E2212

EXPERIMENTAL
Drug: E2212

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

E2212DRUG

single ascending doses ranging from 10mg to 250mg

Drug E2212
placeboDRUG

a single dose of matching placebo

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening;
  • Body mass index (BMI) 18 and 30 kg/m2 at Screening;
  • Are willing and able to comply with all aspects of the protocol; and
  • Provide written informed consent.

You may not qualify if:

  • Clinically important abnormalities on physical examination, vital signs or clinical laboratories.
  • History of serious medical illness
  • Smoking or use of tobacco-containing products within past 3 months
  • History of alcohol or drug abuse within past 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Overland Park, Kansas, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Philip Lee, Md

    Quintiles Phase One Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2010

First Posted

October 14, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

November 1, 2012

Last Updated

May 22, 2013

Record last verified: 2013-02

Locations

US(1)