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

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ClinicalTrials.gov Identifier: NCT01716897
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : May 22, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: E2609 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2012
Primary Completion Date : December 2012
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
50 mg E2609 capsule formulation in fasted state
50 mg E2609 capsule formulation
Drug: E2609
50 mg E2609 tablet formulation in fasted state
50 mg E2609 tablet formulation in fasted state
Drug: E2609
50 mg tablet formulation in fed state
50 mg E2609 tablet formulation in fed state
Drug: E2609


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. incidence of Adverse events [ Time Frame: 5.5 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01716897


Locations
United States, California
California Clinical Trials/Parexel
Glendale, California, United States, 91206
Sponsors and Collaborators
Eisai Inc.
Investigators
Principal Investigator: Haykop Gevorkyan California Clinical Trials Medical Group/Parexel
More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01716897     History of Changes
Other Study ID Numbers: E2609-A001-007
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: May 22, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders