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

Eisai

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: E2212; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01221259

E2212-A001-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Drug E2212

Experimental group

Treatment:

Drug: E2212

Placebo

Placebo Comparator group

Treatment:

Drug: placebo