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← Trials/Trial dossier/NCT01221259

CompletedPhase 1

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

Lead sponsor

Eisai Inc.

Asset

E2212

Listed sites

1

Recruiting sites

-

Enrollment

60

actual

Study population

Alzheimer’s disease

Key I/E criterion

Age 18-55

Primary endpoint

Safety and tolerability of single ascending oral doses of E2212 in healthy

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDE2212-A001-001
NCT IDNCT01221259

Timeline

Milestones

Study start2010-01 (month precision)
Study first posted2010-10-14estimated
Primary completion2011-10actual (month precision)
Study completion2012-11actual (month precision)
Last update posted2013-05-22estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

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

Time frame:21 days

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.