A Randomized, Double-blind, Placebo-controlled, Sequential Ascending, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2212 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01221259

Enrollment

Registered

2010-10-14

Start date

2010-01-31

Completion date

2012-11-30

Last updated

2013-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

DRUGE2212

single ascending doses ranging from 10mg to 250mg

DRUGplacebo

a single dose of matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy men and women of non-child bearing potential age 18 and 55 years old at the time of Screening; 2. Body mass index (BMI) 18 and 30 kg/m2 at Screening; 3. Are willing and able to comply with all aspects of the protocol; and 4. Provide written informed consent.

Exclusion criteria

1. Clinically important abnormalities on physical examination, vital signs or clinical laboratories. 2. History of serious medical illness 3. Smoking or use of tobacco-containing products within past 3 months 4. History of alcohol or drug abuse within past 2 years

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of single ascending oral doses of E2212 in healthy subjects.	21 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026