Partial Onset EpilepsyPhase 1NCT01209858
A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
A Phase 1 study testing Perampanel and Microgynon-30 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 effects of perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC containing EE and LN (Microgynon-30) on the PK of a… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Partial Onset Epilepsy
- What is being tested?
- Perampanel and Microgynon-30
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Oct 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects, aged 18 - 55 years old inclusive at Screening;
- Body mass index (BMI) within the range of 18-32 kg/m^2 inclusive at Screening;
- Must not be taking any form of hormonal contraceptives, including hormonal intrauterine device (IUD), for at least 8 weeks prior to dosing;
- All females must have a negative serum beta human chorionic gonadotropin (B- hCG) test result at Screening and negative urine B-hCG test result at each Baseline. Females of child-bearing potential must agree to use 2 medically acceptable methods of contraception (eg, abstinence where this is the subject's preferred lifestyle, a non-hormonal intrauterine device, a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 4 weeks after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as at least 12 months consecutive amenorrhea, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (ie, bilateral tubal ligation with surgery at least 1 month prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing);
- With no known contraindication to Microgynon-30;
- Are willing and able to comply with all aspects of the protocol; and
- Provide written informed consent.
Who cannot join
- Have evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery (including cholecystectomy) that could impact the PK of the study drug;
- Have a known history of clinically significant drug or food allergies or are presently experiencing seasonal allergies;
- Have an inability to tolerate venipuncture and/or venous access;
- Have a history of alcohol abuse (within the past 6 months) or who drink more than the maximum recommended number of units of alcohol per week (14 units for women) or who are unwilling to abstain from consumption of alcohol throughout the periods of in-patient confinement;
- Have a history of drug abuse or dependence or have a positive result from a urine drug screening test;
- Received any experimental drug within the 12 weeks leading up to the start of study drug treatment or who are currently enrolled in another clinical trial;
Show all 18Show fewer
- Smoke more than 5 cigarettes (or equivalent amount of tobacco) per day or who are unwilling to abstain from the use of nicotine-containing products throughout the period of in-patient confinement;
- Consume more than 5 caffeinated beverages per day (eg, 5 cups of tea, coffee or cans of cola) or who are unwilling to abstain from consumption of caffeine-containing food and beverages throughout the periods of in-patient confinement;
- Have taken any inhibitor of CYP450 within 2 weeks prior to the first dosing (eg, grapefruit, grapefruit juice, grapefruit-containing beverages, apple or Seville orange products);
- Donated blood or blood products within 12 weeks prior to the start of dosing or who intent to donate blood during the study or within 8 weeks of completion of the study;
- With a QTcF interval greater than 450 msec at Screening or either Baseline or a family history of prolonged QTc syndrome or sudden death;
- With a positive result Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCVAb) screen at Screening;
- Have been diagnosed with acquired immune deficiency syndrome (AIDS), or test positive for human immunodeficiency virus (HIV) at Screening;
- With a positive alcohol test at Screening or at either Baseline;
- With a Screening hemoglobin below the lower limit of normal [LLN] and/or with hematological parameters consistent with acute or chronic blood loss (hematocrit [Hct] below the LLN, mean corpuscular hemoglobin [MCH] below LLN and mean corpuscular hemoglobin concentration [MCHC] below LLN);
- Taking, or have taken, any prescribed or over-the-counter drug or herbal remedies in the 2 weeks prior to Screening (unless the OTC drug has a long half-life [ie, 5 x t1/2 greater than 2 weeks]) with the exception of paracetamol, which is allowed up to 12 hours prior to dosing;
- Within 4 weeks prior to dosing, are on special diets or have taken dietary aids that are known to induce CYP3A4 (eg, St John's Wort); or
- Have a known personal or family history of arterial/venous thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
The purpose of this study is to investigate the effects of perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Read the detailed description
This will be an open-label, non-randomized, fixed sequence study in healthy female subjects. The study has 2 parts: Part A investigating the effects of steady state perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC) containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and Part B investigating the effects of repeated dosing of an OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
- Conditions
- Partial Onset Epilepsy
- Being tested
- Perampanel and Microgynon-30
- 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.
Perampanel and Microgynon-30Drug
Part A: Microgynon-30 single oral dose on Day 1 Period 1 and Day 35 Period 2; perampanel oral daily dose starting at 4 mg per day Period 2 from Days 1 through 35 and titrated weekly.
Perampanel and Microgynon-30Drug
Part B: Perampanel single oral dose of 6 mg on Day 1 Period 1 and Day 21 Period 2; Microgynon-30 orally from Day 1 through Day 21 of Period 2.
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Not described Receives: Drug: Perampanel and Microgynon-30 |
| Experimental 2 | Experimental | Not described Receives: Drug: Perampanel and Microgynon-30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LN)
Measured: Up to 24 hours postdose on Days 1 (Tr Pd 1) and 35 (Tr Pd 2).
Part B: Pharmacokinetics (PK) of perampanel
Measured: Up to 72 hours postdose on Days 1 (Tr Pd 1) and 21 (Tr Pd 2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof Tim Mant, Principal investigator, Quintiles, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209858
- Sponsor's protocol ID
- E2007-E044-029
- Status last verified
- May 2013
- First submitted
- 24 Sep 2010
- Last updated
- 17 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT01209858
- Acronym / sponsor ID
- E2007-E044-029
- Conditions
- Partial Onset Epilepsy
- Keywords
- epilepsy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Sep 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 effects of perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Detailed description
This will be an open-label, non-randomized, fixed sequence study in healthy female subjects. The study has 2 parts: Part A investigating the effects of steady state perampanel on the pharmacokinetics (PK) of a single-dose oral contraceptive (OC) containing ethinylestradiol (EE) and levonorgestrel (LN) (Microgynon-30) and Part B investigating the effects of repeated dosing of an OC containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Drug: Perampanel and Microgynon-30 |
| Experimental 2 | Experimental | Drug: Perampanel and Microgynon-30 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy female subjects, aged 18 - 55 years old inclusive at Screening;
- Body mass index (BMI) within the range of 18-32 kg/m^2 inclusive at Screening;
- Must not be taking any form of hormonal contraceptives, including hormonal intrauterine device (IUD), for at least 8 weeks prior to dosing;
- All females must have a negative serum beta human chorionic gonadotropin (B- hCG) test result at Screening and negative urine B-hCG test result at each Baseline. Females of child-bearing potential must agree to use 2 medically acceptable methods of contraception (eg, abstinence where this is the subject's preferred lifestyle, a non-hormonal intrauterine device, a double-barrier method such as condom + spermicide or condom + diaphragm with spermicide, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 4 weeks after study drug discontinuation. The only subjects who will be exempt from this requirement are postmenopausal women (defined as at least 12 months consecutive amenorrhea, in the appropriate age group, without other known or suspected primary cause) or subjects who have been sterilized surgically or who are otherwise proven sterile (ie, bilateral tubal ligation with surgery at least 1 month prior to dosing, hysterectomy, or bilateral oophorectomy with surgery at least 1 month prior to dosing);
- With no known contraindication to Microgynon-30;
Key exclusion criteria (18 listed)
- Have evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery (including cholecystectomy) that could impact the PK of the study drug;
- Have a known history of clinically significant drug or food allergies or are presently experiencing seasonal allergies;
- Have an inability to tolerate venipuncture and/or venous access;
- Have a history of alcohol abuse (within the past 6 months) or who drink more than the maximum recommended number of units of alcohol per week (14 units for women) or who are unwilling to abstain from consumption of alcohol throughout the periods of in-patient confinement;
- Have a history of drug abuse or dependence or have a positive result from a urine drug screening test;
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 |
|---|---|---|
| Perampanel and Microgynon-30Part A: Microgynon-30 single oral dose on Day 1 Period 1 and Day 35 Period 2; perampanel oral daily dose starting at 4 mg per day Period 2 from Days 1 through 35 and titrated weekly. | Drug | Experimental 1 |
| Perampanel and Microgynon-30Part B: Perampanel single oral dose of 6 mg on Day 1 Period 1 and Day 21 Period 2; Microgynon-30 orally from Day 1 through Day 21 of Period 2. | Drug | Experimental 2 |
Primary outcome
Part A: Pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LN)
Time frame: Up to 24 hours postdose on Days 1 (Tr Pd 1) and 35 (Tr Pd 2).
Part B: Pharmacokinetics (PK) of perampanel
Time frame: Up to 72 hours postdose on Days 1 (Tr Pd 1) and 21 (Tr Pd 2).
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 17 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.
Prof Tim Mant principal investigator
Quintiles, Inc.
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 and Microgynon-30 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 7 inclusion and 18 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 17 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?
Part A: Pharmacokinetics (PK) of ethinylestradiol (EE) and levonorgestrel (LN) (time frame: Up to 24 hours postdose on Days 1 (Tr Pd 1) and 35 (Tr Pd 2).). The study lists 2 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 17 May 2013.