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

NCT01716897 | Completed Phase 1

• 1 other identifier: E2609-A001-007
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• AUC(0-inf) ratio, new tablet vs. capsule

  0 -144 hours

• AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet

  0 - 144 hours

• Cmax ratio, new tablet vs. capsule

  0 - 144 hours

• Cmax ratio, fed state vs. fasted state, both after administration of new tablet

  0 - 144 hours

Secondary Outcomes (1)

• incidence of Adverse events

  5.5 weeks

Study Arms (3)

50 mg E2609 capsule formulation in fasted state

OTHER

50 mg E2609 capsule formulation

Drug: E2609

50 mg E2609 tablet formulation in fasted state

OTHER

50 mg E2609 tablet formulation in fasted state

Drug: E2609

50 mg tablet formulation in fed state

OTHER

50 mg E2609 tablet formulation in fed state

Drug: E2609

Interventions

E2609 DRUG

50 mg E2609 capsule formulation in fasted state; 50 mg E2609 tablet formulation in fasted state; 50 mg tablet formulation in fed state

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

California Clinical Trials/Parexel

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Haykop Gevorkyan

  California Clinical Trials Medical Group/Parexel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 30, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: May 22, 2013

Record last verified: 2013-02

Locations

US (1)