AZD3241 Extended release formulation study

• Research type

  Research Study

• Full title

  A Phase I, Single-Centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) after Administration of Multiple Doses in Healthy Male and Female Subjects Including the Effect of Food

• IRAS ID

  89101

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-003140-42

• Research summary

  AZD3241 is being developed as a treatment for patients with Parkinson's disease and related disorders. AZD3241 has been given to human volunteers in three previous studies. A total of 126 healthy volunteers have received AZD3241. As AZD3241 is broken down quickly by the body, a 100mg extended release (ER) formulation was tested in a previous study. The purpose of this study is to develop a 300mg ER tablet suitable for use in patients. We are looking at the body??s breakdown of the drug, and how food affects this. Another purpose is to find out how safe and well-tolerated AZD3241 is when the daily dose is increased over an eight-day period. Approximately 32 healthy volunteers will be included in the study to achieve at least 24 evaluable subjects. The duration of the study is approximately 50 days. This includes screening period of up to 30 days, one 10-day residential treatment period, visits on the first 2 days post-discharge, and a follow up visit 7 to 13 days after the last dose administration. An optional part of this study involves the collection of a blood sample for genetic (DNA) and/or biological research. AZD3241 is being developed by AstraZeneca and this study is being carried out on their behalf by Quintiles Drug Research Unit at Guy??s Hospital.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1475

• Date of REC Opinion

  3 Nov 2011

• REC opinion

  Further Information Favourable Opinion