A Study of UE2343 in Healthy Volunteers

• Research type

  Research Study

• Full title

  A Phase I Double-Blind, Randomised, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral UE2343 in Healthy Subjects

• IRAS ID

  118223

• Contact name

  SALVATORE FEBBRARO

• Sponsor organisation

  University of Edinburgh, Endocrinology Unit, Centre for Cardiovascular Science

• Eudract number

  2012-004158-27

• ISRCTN Number

  to be registered

• Research summary

  The purpose of this study is to investigate a new drug called UE2343 and to assess the effect it has on the body when different amounts are given. The study will also look at how quickly UE2343 enters the bloodstream, is distributed in the blood, broken down and disposed of by the body when it is taken as a single dose. The study is to find out the safe amount of drug that can be given to patients. This is the first time UE2343 will be studied in healthy volunteers. UE2343 is a medicine that is not currently ??on the market??, but is being developed with the intention to treat patients with Alzheimer??s disease. Alzheimer's disease is the most common form of dementia. Dementia is a group of symptoms associated with a decline in the way your brain functions, affecting your memory and the way you behave. The study will consist of 6 groups of 8 subjects receiving a single dose of UE2343 (or placebo). UE2343 and matching placebo are capsules which must be taken with water. Safety parameters will be measured at pre-determined time-points during the study. Adverse events will also be continuously monitored. Blood samples will be taken to measure the levels of drug.

• REC name

  Wales REC 1

• REC reference

  12/WA/0297

• Date of REC Opinion

  12 Nov 2012

• REC opinion

  Favourable Opinion