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

October 23, 2012
May 20, 2013
October 2012
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01716897 on ClinicalTrials.gov Archive Site
incidence of Adverse events [ Time Frame: 5.5 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: E2609
  • 50 mg E2609 capsule formulation in fasted state
    50 mg E2609 capsule formulation
    Intervention: Drug: E2609
  • 50 mg E2609 tablet formulation in fasted state
    50 mg E2609 tablet formulation in fasted state
    Intervention: Drug: E2609
  • 50 mg tablet formulation in fed state
    50 mg E2609 tablet formulation in fed state
    Intervention: Drug: E2609
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
February 2013
December 2012   (final data collection date for primary outcome measure)

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
Male
30 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01716897
E2609-A001-007
No
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Haykop Gevorkyan California Clinical Trials Medical Group/Parexel
Eisai Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP