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

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

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
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: February 2013

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

• 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

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
• Other Study ID Numbers: E2609-A001-007
• First Posted: October 30, 2012
• 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