- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01209858
A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
May 15, 2013 updated by: Eisai Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
48
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
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London, United Kingdom
- Quintiles Ltd
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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
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
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: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Experimental 1
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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.
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.
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EXPERIMENTAL: Experimental 2
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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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
|
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).
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Up to 72 hours postdose on Days 1 (Tr Pd 1) and 21 (Tr Pd 2).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Prof Tim Mant, Quintiles, Inc.
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
March 1, 2010
Primary Completion (ACTUAL)
October 1, 2010
Study Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
September 24, 2010
First Submitted That Met QC Criteria
September 24, 2010
First Posted (ESTIMATE)
September 27, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
May 17, 2013
Last Update Submitted That Met QC Criteria
May 15, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Physiological Effects of Drugs
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Contraceptives, Postcoital, Synthetic
- Contraceptives, Postcoital
- Contraceptives, Postcoital, Hormonal
- Ethinyl estradiol, levonorgestrel drug combination
- Ethinyl Estradiol-Norgestrel Combination
Other Study ID Numbers
- E2007-E044-029
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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