Phase 1, open-label PET study in healthy volunteers after oral TAK-831

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Subjects to Determine D-Amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-Dose Oral Administration (HMR code: 15-031)

• IRAS ID

  196921

• Contact name

  Frans van den berg

• Contact email

  rec@hmrlondon.com

• Sponsor organisation

  Takeda Development Centre Europe Ltd.

• Eudract number

  2015-004509-17

• Clinicaltrials.gov Identifier

  NCT02716987

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  TAK-831 is an experimental new treatment for symptoms linked to a part of the brain called the cerebellum. When the cerebellum doesn’t work properly, it can affect how people think, feel or behave. It can also affect people’s balance, limb coordination, eye movements and speech. We hope that TAK-831 will improve cerebellum function by binding to a substance in the brain called D-amino acid oxidase (DAO). \n\nWe’re doing this study in up to 22 healthy men, aged 25–55 years. We’ll measure how much TAK-831 binds DAO in the brain and its effects on brain activity, using PET (positron emission tomography) and fMRI (functional magnetic resonance imaging) scans, which make images of the brain. We’ll also assess blood levels of TAK-831 and substances linked to cerebellum function, and whether TAK-831 has any side effects. \n\nThe study has 2 parts. All participants will have 2 screening visits and 2 study sessions. In Part A, participants will take a single dose of TAK-831 and have 3 PET and fMRI scans. They’ll stay on the ward for 3 nights and have 1 follow-up visit and 1 follow-up telephone call. In Part B, participants will have 2 PET scans, stay on the ward for 2 nights, and have 1 follow-up telephone call. Participants will take up to 9 weeks to finish the study. \n\nBefore each PET scan, we’ll give participants an injection of radioactive tracer containing fluorine-18; the tracer binds to DAO in the brain, and the PET scan shows where the tracer is. Participants will be exposed to radiation similar to 4 years’ background radiation in Part A, and 3 years’ background radiation in Part B. \n\nA pharmaceutical company, Takeda Development Centre Europe Ltd, is funding the study. \n\nThe study will take place at 1 research unit and 1 imaging centre in London.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  15/LO/1916

• Date of REC Opinion

  26 Jan 2016

• REC opinion

  Further Information Favourable Opinion