Phase 1 ADME study of valproate in healthy females (QSC118091)

• Research type

  Research Study

• Full title

  An open-label study of excretion balance and pharmacokinetics following a single oral dose of [14C]-sodium valproate (3.7 MBq) in healthy postmenopausal or permanently sterile female subjects.

• IRAS ID

  248740

• Sponsor organisation

  Sanofi-Aventis Groupe

• Eudract number

  2017-004987-36

• Duration of Study in the UK

  0 years, 2 months, 25 days

• Research summary

  The Sponsor is investigating a currently marketed medicine, sodium valproate, which is used to treat seizures which are associated with epilepsy. Epilepsy is a common condition that affects the brain and causes frequent seizures. Seizures are bursts of electrical activity in the brain that temporarily affects how it works, and can lead to jerking and shaking (known as a fit), losing awareness and collapsing.

  The study will try to identify the out how fast the test medicine is broken down and how it is removed from the body when given to healthy female volunteers. This is achieved by giving a radiolabelled formulation (recipe) of the test medicine. Radiolabelled means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body.

  The study will enrol up to 6 healthy female volunteers who are not able to have children. The volunteers will receive one dose of the study drug as a solution to drink on Day 1. Volunteers will remain in clinic until Day 8 and be discharged from the clinical unit once the discharge criteria for radioactivity recovery have been met. If the discharge criteria are not met by Day 8, volunteers may remain in the clinical unit for up to an additional 7 days and released as a group prior to or on Day 15. If the discharge criteria are not met on Day 15, volunteers will return to the clinical unit weekly for a maximum of 4 additional weeks. Volunteers will have a follow up visit 7 – 10 days after their last sample collection or on the last return visit (Day 43).

• REC name

  HSC REC A

• REC reference

  18/NI/0139

• Date of REC Opinion

  28 Aug 2018

• REC opinion

  Favourable Opinion