An MRI study to assess the effects of BIIB104 on brain activity

• Research type

  Research Study

• Full title

  A Phase 1 Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Sequence Crossover Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry Using BOLD Functional MRI and Arterial Spin Labeling in Healthy Participants. HMR code (19-003)

• IRAS ID

  269400

• Contact name

  Denisa Wilkes

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  Biogen

• Eudract number

  2019-001104-38

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  The study medicine (BIIB104) is an experimental new medicine intended to treat conditions like memory loss and lack of concentration that are linked to illnesses like schizophrenia. Currently, there are no medicines that treat these symptoms.
  We hope the study medicine will increase the activity of sites in the brain, called AMPA receptors, which regulate levels of substances linked to learning and memory, and hopefully will lead to improve learning and memory in patients with illnesses such as schizophrenia.
  Participants will have up to 2 screening visits, during which they’ll have an MRI (Magnetic Resonance Imaging) scan. Eligible participants (up to 30 healthy men, aged 21–45 years) will have 2 study sessions and take twice daily doses of up to 0.8 mg study medicine (single dose of 0.3 mg study medicine on Day 4) in one session and dummy medicine in the other, each for 4 days. Participants will have 4 on-treatment MRI scans (2 in each study session), to measure the effects of the study medicine on brain activity while they complete simple tasks during every scan. We’ll also be checking for side effects that the study medicine may cause during the study.

  Participants will take up to 9 weeks to finish the study. There’ll be a gap of up to 2 weeks between each session and 1 follow-up phone call. They’ll stay on the ward for 4 nights in each session.

  A pharmaceutical company Biogen Idec Ltd. is funding the study.

  The study will take place at 1 research centre and 1 imaging centre in London.

• REC name

  HSC REC B

• REC reference

  19/NI/0160

• Date of REC Opinion

  26 Sep 2019

• REC opinion

  Further Information Favourable Opinion