Effect of VX-222 on the PK of Oral Contraceptives in Healthy Females

• Research type

  Research Study

• Full title

  A Phase 1, Randomised, Double-Blind, Placebo-Controlled, 2-Period, 2-Sequence Crossover Study to Investigate the Effect of VX-222 on the Pharmacokinetics of Oral Contraceptives and to Investigate the Pharmacokinetics, Safety, and Tolerability of VX-222 in Healthy Female Subjects.

• IRAS ID

  46967

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Vertex Pharmaceuticals (Europe) Ltd

• Eudract number

  2009-016979-29

• Research summary

  The purpose of this study is to determine if VX-222 (a drug being developed for the treatment of Hepatitis C Virus infection) will affect the way that oral contraceptives are broken down by the body, thereby altering the effectiveness of the oral contraceptive. Approximately eighteen subjects will be enrolled such that at least 14 complete the study. Each subject will take part in two treatment periods with a washout period of 14 days between the two. Subjects will be randomly assigned to one of two treatment sequences. Treatments to be received at each treatment period as follows: Treatment Sequence A: Treatment Period 1 receive VX-222 1500mg twice daily on Days 1 to 14 inclusive and Microgynon (30 æg Ethinyl Estradiol, 150 æg Levonorgestrol). Treatment Period 2 receive VX-222 placebo twice daily on Days 1 to 14 inclusive and Microgynon (30 æg Ethinyl Estradiol, 150 æg Levonorgestrol). Treatment Sequence B: Treatment Period 1 receive VX-222 placebo twice daily on Days 1 to 14 inclusive and Microgynon (30 æg Ethinyl Estradiol, 150 æg Levonorgestrol). Treatment Period 2 receive VX-222 1500mg twice daily on Days 1 to 14 inclusive and Microgynon (30 æg Ethinyl Estradiol, 150 æg Levonorgestrol). Intensive blood sampling will be performed on Days 1 and 14 of each treatment period, to determine how the levels of VX-222 and microgynon in the blood change over time on those days. A thorough post study safety assessment will be performed approximately 7 to 10 days after the last dose of study drug at the second treatment period. The dose level of microgynon to be used in this study is the marketed dose level for contraception, and is commonly used in oral contraceptive interaction studies. The difference between the levels of microgynon in the blood at each treatment period will be compared to determine the effect of the VX-222 administration on the break down of microgynon within the body.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/1

• Date of REC Opinion

  21 Apr 2010

• REC opinion

  Further Information Favourable Opinion