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CompletedNCT01716897Updated May 22, 2013

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

A Phase 1 interventional study of E2609 in Alzheimer's Disease, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to male participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-05-22.

Sponsored by Eisai Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
Male
01

Study summary

This study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet formulation administered under fed and fasted conditions in healthy subjects.

02

Conditions studied

  • Alzheimer's Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

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Lead sponsor

Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Other
    50 mg E2609 capsule formulation in fasted state

    50 mg E2609 capsule formulation

    Drug: E2609

  • Other
    50 mg E2609 tablet formulation in fasted state

    50 mg E2609 tablet formulation in fasted state

    Drug: E2609

  • Other
    50 mg tablet formulation in fed state

    50 mg E2609 tablet formulation in fed state

    Drug: E2609

Interventions

  • DrugE2609
06

What researchers measure

Primary outcomes

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

    Time frame: 0 -144 hours

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

    Time frame: 0 - 144 hours

  3. Cmax ratio, new tablet vs. capsule

    Time frame: 0 - 144 hours

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

    Time frame: 0 - 144 hours

Secondary outcomes

  1. incidence of Adverse events

    Time frame: 5.5 weeks

07

Study locations

1 site
  • California Clinical Trials/Parexel
    Glendale, California 91206, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01716897
Lead sponsor
Eisai Inc.
Responsible party
Sponsor
First posted
Oct 30, 2012
Start date
Oct 2012
Primary completion
Dec 2012
Completion
Feb 2013
Last update
May 22, 2013

Study contacts

Haykop Gevorkyan
principal investigator · California Clinical Trials Medical Group/Parexel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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