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

NCT ID: NCT01716897

Last Updated: 2013-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-02-28

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50 mg E2609 capsule formulation in fasted state

50 mg E2609 capsule formulation

Group Type: OTHER

E2609

Intervention Type: DRUG

50 mg E2609 tablet formulation in fasted state

50 mg E2609 tablet formulation in fasted state

Group Type: OTHER

E2609

Intervention Type: DRUG

50 mg tablet formulation in fed state

50 mg E2609 tablet formulation in fed state

Group Type: OTHER

E2609

Intervention Type: DRUG

Interventions

E2609

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haykop Gevorkyan

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials Medical Group/Parexel

Locations

California Clinical Trials/Parexel

Glendale, California, United States

Countries

United States

Other Identifiers

E2609-A001-007

Identifier Type: -

Identifier Source: org_study_id