An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E2609
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria
- Caucasian males defined as persons of a European or Latin American descent
- Healthy male 30 to 55 years inclusive at the time of informed consent
- Body mass index (BMI) of 18 to 32 kg/m2 at Screening
- 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
- 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
- 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
- Any history of cerebrovascular disease (stroke or transient ischemic attack)
- 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
- 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
- Hypersensitivity to the study drugs or any of their excipients
Sites / Locations
- California Clinical Trials/Parexel
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
50 mg E2609 capsule formulation in fasted state
50 mg E2609 tablet formulation in fasted state
50 mg tablet formulation in fed state
Arm Description
50 mg E2609 capsule formulation
50 mg E2609 tablet formulation in fasted state
50 mg E2609 tablet formulation in fed state
Outcomes
Primary Outcome Measures
AUC(0-inf) ratio, new tablet vs. capsule
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
Cmax ratio, new tablet vs. capsule
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
Secondary Outcome Measures
incidence of Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01716897
Brief Title
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg E2609 capsule formulation in fasted state
Arm Type
Other
Arm Description
50 mg E2609 capsule formulation
Arm Title
50 mg E2609 tablet formulation in fasted state
Arm Type
Other
Arm Description
50 mg E2609 tablet formulation in fasted state
Arm Title
50 mg tablet formulation in fed state
Arm Type
Other
Arm Description
50 mg E2609 tablet formulation in fed state
Intervention Type
Drug
Intervention Name(s)
E2609
Primary Outcome Measure Information:
Title
AUC(0-inf) ratio, new tablet vs. capsule
Time Frame
0 -144 hours
Title
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
Time Frame
0 - 144 hours
Title
Cmax ratio, new tablet vs. capsule
Time Frame
0 - 144 hours
Title
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
Time Frame
0 - 144 hours
Secondary Outcome Measure Information:
Title
incidence of Adverse events
Time Frame
5.5 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria
Caucasian males defined as persons of a European or Latin American descent
Healthy male 30 to 55 years inclusive at the time of informed consent
Body mass index (BMI) of 18 to 32 kg/m2 at Screening
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
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
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
Any history of cerebrovascular disease (stroke or transient ischemic attack)
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
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
Hypersensitivity to the study drugs or any of their excipients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haykop Gevorkyan
Organizational Affiliation
California Clinical Trials Medical Group/Parexel
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Clinical Trials/Parexel
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
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