Partial Onset EpilepsyPhase 1NCT01240187
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
A Phase 1 study testing perampanel in people with Partial Onset Epilepsy, run by Eisai Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Onset Epilepsy
- What is being tested?
- perampanel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Sep 2010
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects aged between 18-55 years.
- BMI of 18-32 kg/m ^2.
- Willing and able to provide written informed consent.
Who cannot join
- Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
- Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
- Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
- Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
- Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
- Subjects who consume more than five caffeinated beverages per day.
Show all 9Show fewer
- Subjects who smoke more than 5 cigarettes per day.
- Subjects with a history of drug abuse or who have a positive urine drug screening test.
- Women who do not agree to use two methods of contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.
Read the detailed description
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.
- Conditions
- Partial Onset Epilepsy
- Being tested
- perampanel
- Keywords
- epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perampanelDrug
Single dose of 6 tablets 2 mg orally
perampanelDrug
Single dose of 1 tablet 12 mg orally
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Not described Receives: Drug: perampanel |
| Experimental 2 | Experimental | Not described Receives: Drug: perampanel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Onset EpilepsyStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Joanne Collier, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240187
- Sponsor's protocol ID
- E2007-E044-037
- Status last verified
- May 2011
- First submitted
- 23 Sep 2010
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Study to Demonstrate Bioequivalence Between 6 x2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01240187
- Acronym / sponsor ID
- E2007-E044-037
- Conditions
- Partial Onset Epilepsy
- Keywords
- epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Nov 2010 (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.
The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.
Detailed description
A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: perampanel |
| Experimental 2 | Experimental | Drug: perampanel |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects aged between 18-55 years.
- BMI of 18-32 kg/m ^2.
- Willing and able to provide written informed consent.
Key exclusion criteria (9 listed)
- Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
- Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
- Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
- Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
- Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
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 |
|---|---|---|
| perampanelSingle dose of 6 tablets 2 mg orally | Drug | Experimental 1 |
| perampanelSingle dose of 1 tablet 12 mg orally | Drug | Experimental 2 |
Primary outcome
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.
Time frame: 12 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 14 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.
Dr Joanne Collier principal investigator
Quotient Clinical
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 perampanel in people with Partial Onset Epilepsy, run by Eisai Inc. at 1 site in United Kingdom.
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 3 inclusion and 9 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 14 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 Kingdom. 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?
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet. (time frame: 12 weeks). 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 14 May 2013.