Brain uptake of GSK356278: a PET scan study; version 1

• Research type

  Research Study

• Full title

  An open label positron emission tomography study in healthy male subjects to investigate brain PDE4 engagement, pharmacokinetics and safety of single oral doses of GSK356278, using [11C]-(R)-rolipram as a PET ligand(s). (HMR code 11-019)

• IRAS ID

  90006

• Contact name

  Benjamin van Hecke

• Sponsor organisation

  GlaxoSmithKline Research & Development China

• Eudract number

  2011-004118-41

• Research summary

  The study medicine is an experimental treatment for Huntington??s disease: a genetic condition that causes brain damage. There??s no cure for Huntington??s disease, and it gets worse over time, leading eventually to death. We hope that the study medicine will improve symptoms and slow down any further damage to the brain, by blocking sites in the brain called PDE4 (phosphodiesterase 4 enzymes). We'll test single doses of the study medicine in 12 healthy men, aged 25??55 years. We aim to find out: how much study medicine attaches itself (??binds??) to brain PDE4; and the study medicine??s side effects and blood levels. To measure how much study medicine binds to PDE4 in the brain, We'll do PET (positron emission tomography) brain scans before and after participants take the study medicine. During each PET scan, the participant will receive an injection of a small dose of radioactive tracer (containing carbon-11). The tracer binds to PDE4 in the brain, and the PET scan shows where the tracer is. Participants will have 3 PET scans, and be exposed to just over twice the total amount of background radiation that the average UK resident is exposed to each year. That amount of radiation is a negligible risk to health. Participants will take up to 7 weeks to finish the study. They??ll make up to 4 outpatient visits, and stay on the ward for 4 nights. A pharmaceutical company, GlaxoSmithKline Research & Development Limited, is funding the study. The study will take place at 1 research centre in London. The PET scans will be done in a unit nearby. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  Scotland A REC

• REC reference

  11/IE/0155

• Date of REC Opinion

  15 Nov 2011

• REC opinion

  Further Information Favourable Opinion