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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716897
• Other study ID #: E2609-A001-007
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2012
• Last updated: May 20, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• E2609

Locations

Country	Name	City	State
United States	California Clinical Trials/Parexel	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC(0-inf) ratio, new tablet vs. capsule		0 -144 hours	No
Primary	AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet		0 - 144 hours	No
Primary	Cmax ratio, new tablet vs. capsule		0 - 144 hours	No
Primary	Cmax ratio, fed state vs. fasted state, both after administration of new tablet		0 - 144 hours	No
Secondary	incidence of Adverse events		5.5 weeks	Yes