To investigate the effect of Perampanel on Microgynon-30

• Research type

  Research Study

• Full title

  An Open-label Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel with Oral Contraceptives in Healthy Female Subjects

• IRAS ID

  43539

• Contact name

  Tim Mant

• Sponsor organisation

  Eisai Limited

• Eudract number

  2009-013170-40

• ISRCTN Number

  xx

• Research summary

  The drug being investigated in this study is Perampanel. The aim of the study is to investigate if Perampanel causes an effect on the combined oral contraceptive Microgynon-30 and vice versa in healthy female subjects. In addition, we will investigate the effect Perampanel has on the electrocardiogram (electrical tracing of the heart) in healthy female volunteers. The study will take place at Quintiles Drug Research Unit, and will be in 2 parts - Part A and B. We will recruit approximately 48 volunteers in total (24 volunteers in Part A and 24 volunteers in Part B) Part A will consist of one screening visit, one in-patient period of 3 days (2 nights), one in-patient period of 44 days (43 nights) and one follow-up visit. Total duration of Part A will be approximately 13 weeks. Part B will consist of one screening visit, one in-patient period of 5 days (4 nights), one in-patient period of 25 days (24 nights) and one follow-up visit. Total duration of Part B will be approximately 11 weeks. The information gained in this study will extend the sponsor??s knowledge about the effect of Perampanel on Microgynon-30 and vice-versa. The study will also help shed more light on the effect Perampanel has on the electrocardiogram in healthy female subjects.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/3

• Date of REC Opinion

  17 Feb 2010

• REC opinion

  Further Information Favourable Opinion