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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01716897
First received: October 23, 2012
Last updated: May 20, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: E2609
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • AUC(0-inf) ratio, new tablet vs. capsule [ Time Frame: 0 -144 hours ] [ Designated as safety issue: No ]
  • AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet [ Time Frame: 0 - 144 hours ] [ Designated as safety issue: No ]
  • Cmax ratio, new tablet vs. capsule [ Time Frame: 0 - 144 hours ] [ Designated as safety issue: No ]
  • Cmax ratio, fed state vs. fasted state, both after administration of new tablet [ Time Frame: 0 - 144 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of Adverse events [ Time Frame: 5.5 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01716897     History of Changes
Other Study ID Numbers: E2609-A001-007
Study First Received: October 23, 2012
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014