GSK1223249

• Research type

  Research Study

• Full title

  A Single and Repeat Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of GSK1223249 in Patients with ALS.

• IRAS ID

  14708

• Sponsor organisation

  GlaxoSmithkline

• Eudract number

  HM2008/00004/00

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  The drug being tested in this study is GSK1223249. It is being developed by GlaxoSmithKline to treat symptoms in patients with Amyotrophic Lateral Sclerosis (ALS). The drug works by inhibiting the protein that prevents nerve growth.This will be the first time the drug will be given to man. The trial is expected to involve approximately 76 volunteers.The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses or repeat dose escalation in volunteers with ALS.The screening for the study will take place at King`s College London, the admission and dosing of volunteers will take place at Guy`s Drug Research Unit (GDRU).The admission will involve a night residency in GDRU on the day before dosing.Following dosing patients will be monitored for at least 24hrs in part 1 and first dose in part 2. They will be monitored for at least 6 hours following second dose in part 2. Patients will be discharged from the unit after safety assessments have been carried out and would attend follow up clinics at King`s College London.The information gained in this study will help the sponsor of this study to determine whether GSK1223249 is suitable for further studies in patients with ALS.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  09/H0804/1

• Date of REC Opinion

  20 Mar 2009

• REC opinion

  Further Information Favourable Opinion