- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01716897
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
May 20, 2013 updated by: Eisai Inc.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Glendale, California, United States, 91206
- California Clinical Trials/Parexel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 50 mg E2609 capsule formulation in fasted state
50 mg E2609 capsule formulation
|
|
OTHER: 50 mg E2609 tablet formulation in fasted state
|
|
OTHER: 50 mg tablet formulation in fed state
50 mg E2609 tablet formulation in fed state
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
AUC(0-inf) ratio, new tablet vs. capsule
Time Frame: 0 -144 hours
|
0 -144 hours
|
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
Time Frame: 0 - 144 hours
|
0 - 144 hours
|
Cmax ratio, new tablet vs. capsule
Time Frame: 0 - 144 hours
|
0 - 144 hours
|
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
Time Frame: 0 - 144 hours
|
0 - 144 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidence of Adverse events
Time Frame: 5.5 weeks
|
5.5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Haykop Gevorkyan, California Clinical trials medical group/PAREXEL
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
February 1, 2013
Study Registration Dates
First Submitted
October 23, 2012
First Submitted That Met QC Criteria
October 29, 2012
First Posted (ESTIMATE)
October 30, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 22, 2013
Last Update Submitted That Met QC Criteria
May 20, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2609-A001-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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