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CompletedPhase 1

An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption

A Randomized, Open-label, 3-treatment Crossover Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption in Healthy Caucasian Male Adults

Lead sponsor

Eisai Inc.

Asset

Elenbecestat

Listed sites

1

Recruiting sites

-

Enrollment

18

actual

Study population

Alzheimer’s disease

Key I/E criteria

Age 30-55Male

Primary endpoints

AUC(0-inf) ratio, new tabletAUC(0-inf) ratio, fed stateCmax ratio, new tablet

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 IDE2609-A001-007
NCT IDNCT01716897

Timeline

Milestones

Study start2012-10 (month precision)
Study first posted2012-10-30estimated
Primary completion2012-12actual (month precision)
Study completion2013-02actual (month precision)
Last update posted2013-05-22estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age30 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

1. Caucasian males defined as persons of a European or Latin American descent

2. Healthy male 30 to 55 years inclusive at the time of informed consent

3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening

4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation

Exclusion criteria

1. Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures

2. Any medical condition which, in the opinion of the investigator has high risk of seizures (e.g., history of traumatic brain injury associated with loss of consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past 5 years

3. Any history of cerebrovascular disease (stroke or transient ischemic attack)

4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using Fridericia?s formula (QTcF) interval (QTcF \> 450 ms) as demonstrated by the mean of triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or Baseline Period

5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods, e.g. component of the ECG cycle from onset of atrial depolarization to onset of ventricular depolarization (PR)\>220 ms, component of ECG wave representing ventricular depolarization (QRS)\>110 ms

6. Hypersensitivity to the study drugs or any of their excipients

Endpoints (5)

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

5 endpoints
Primary/protocol endpoint

AUC(0-inf) ratio, new tablet vs. capsule

Time frame:0 -144 hours

concentration, descriptive

Primary/protocol endpoint

AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet

Time frame:0 - 144 hours

concentration, descriptive

Primary/protocol endpoint

Cmax ratio, new tablet vs. capsule

Time frame:0 - 144 hours

concentration, descriptive

Primary/protocol endpoint

Cmax ratio, fed state vs. fasted state, both after administration of new tablet

Time frame:0 - 144 hours

concentration, descriptive

Secondary/protocol endpoint

incidence of Adverse events

Time frame:5.5 weeks

event count, event

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.