Open-Label HV study to evaluate VMAT2 blockade using PET_ Version 1

• Research type

  Research Study

• Full title

  An Open-label Study in Healthy Adult Subjects to Evaluate the Effects of Acute Vesicular Monoamine Transporter 2 Receptor (VMAT2) Blockade on the Dopamine Neurotransmitter System Using [11C]PHNO and [18F]DOPA Positron Emission Tomography

• IRAS ID

  286905

• Contact name

  Frans Van Den Berg

• Contact email

  Frans.VanDenBerg@invicro.co.uk

• Sponsor organisation

  Neurocrine Biosciences Inc

• Duration of Study in the UK

  1 years, 0 months, 18 days

• Research summary

  This is an open-label, single oral dose study with Valbenazine in up to 15 healthy subjects using [11C]PHNO and [18F]DOPA PET imaging. The main purpose of the study is to investigate how valbenazine affects the dopamine system in the brain using [11C]PHNO and [18F]DOPA, and to assess the levels of valbenazine in the blood.
  The study drug, valbenazine (a selective orally active vesicular monoamine transporter 2 (VMAT2)) inhibitor for the treatment of adults with tardive dyskinesia. Valbenazine is believed to reduce dopamine release. Subjects will receive two oral doses of valbenazine.

  Up to 15 healthy subjects will be recruited for this study. The study comprises of a screening period, MRI, baseline and post dose [11C]PHNO and [18F]DOPA PET imaging visits and a follow up call post completion of final PET scan. The study is performed at a single research centre located in London, UK
  

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  20/EE/0198

• Date of REC Opinion

  3 Nov 2020

• REC opinion

  Further Information Favourable Opinion