To assess safety/tolerability and effect on biomarkers of AZD3839
Research type
Research Study
Full title
A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect on Biomarkers of AZD3839 Including an Open-label Food Effect Group in Healthy Male and Female Volunteers of Non-childbearing Potential
IRAS ID
79890
Sponsor organisation
AstraZeneca R&D
Eudract number
2011-001337-16
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
AZD3839 is a drug that may be useful in the treatment of Alzheimer??s disease (AD).One of the most widely accepted theories for the cause of AD is the formation and deposition of a protein called amyloid beta in the brain. AZD3839 interferes with the formation of this protein and as such it may be of benefit in slowing down or halting the progression of AD.Approximately 80 healthy male and female volunteers of non-childbearing potential will take part in the total trial, 72 in Part 1 and 8 in Part 2.This is the first time that AZD3839 will be administered to humans in clinical trials. The purpose of this research study is in Part 1, to evaluate safety, tolerability and effect on biomarkers of AZD3839. Also in Part 2 to evaluate the food effect on AZD3839.Part 1: there will be 3 visits to the unit by the volunteer, including a residential visit lasting 5 days/4 nights. Part 2: there will be 4 visits to the unit, including 2 residential visits each lasting between 5 days/4 nights.An optional part of this study involves the collection of a blood sample for genetic (DNA) and/or biological research. AZD3839 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
South Central - Berkshire B Research Ethics Committee
REC reference
11/IE/0045
Date of REC Opinion
31 May 2011
REC opinion
Further Information Favourable Opinion