Alzheimer's DiseasePhase 1NCT01716897
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
A Phase 1 study testing E2609 in people with Alzheimer's Disease, run by Eisai Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- E2609
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials/Parexel
Glendale, California, 91206
About this study
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
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
- Being tested
- E2609
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2609Drug
| Study group | Role | What they receive |
|---|---|---|
| 50 mg E2609 capsule formulation in fasted state | Other | 50 mg E2609 capsule formulation Receives: Drug: E2609 |
| 50 mg E2609 tablet formulation in fasted state | Other | 50 mg E2609 tablet formulation in fasted state Receives: Drug: E2609 |
| 50 mg tablet formulation in fed state | Other | 50 mg E2609 tablet formulation in fed state Receives: Drug: E2609 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-inf) ratio, new tablet vs. capsule
Measured: 0 -144 hours
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
Measured: 0 - 144 hours
Cmax ratio, new tablet vs. capsule
Measured: 0 - 144 hours
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
Measured: 0 - 144 hours
Secondary outcomes (1)
incidence of Adverse events
Measured: 5.5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haykop Gevorkyan, Principal investigator, California Clinical Trials Medical Group/Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716897
- Sponsor's protocol ID
- E2609-A001-007
- Status last verified
- Feb 2013
- First submitted
- 23 Oct 2012
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01716897
- Acronym / sponsor ID
- E2609-A001-007
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 mg E2609 capsule formulation in fasted state | Other | Drug: E260950 mg E2609 capsule formulation |
| 50 mg E2609 tablet formulation in fasted state | Other | Drug: E260950 mg E2609 tablet formulation in fasted state |
| 50 mg tablet formulation in fed state | Other | Drug: E260950 mg E2609 tablet formulation in fed state |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
AUC(0-inf) ratio, new tablet vs. capsule
Time frame: 0 -144 hours
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet
Time frame: 0 - 144 hours
Cmax ratio, new tablet vs. capsule
Time frame: 0 - 144 hours
Cmax ratio, fed state vs. fasted state, both after administration of new tablet
Time frame: 0 - 144 hours
1 secondary outcome
incidence of Adverse events
Time frame: 5.5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haykop Gevorkyan principal investigator
California Clinical Trials Medical Group/Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E2609 in people with Alzheimer's Disease, run by Eisai Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC(0-inf) ratio, new tablet vs. capsule (time frame: 0 -144 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2013.