To assess pharmacokinetics of single doses of AZD8329
Research type
Research Study
Full title
A Randomised, Open-label, Three-way Cross-over, Phase I Study in Healthy Subjects to Assess the Pharmacokinetics of AZD8329 after Single Doses of the Oral Solid Formulation and the Oral Solution.
IRAS ID
64609
Contact name
James Ritter
Sponsor organisation
AstraZeneca AB
Eudract number
2010-022917-24
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The drug being tested in this trial is AZD8329. The primary indication for AZD8329 is planned to be type 2 diabetes mellitus, but there are also potential alternative indications such as obesity and dyslipidemia (abnormal amounts of fat in the blood).The present study will be performed to assess the pharmacokinetics (PK-evaluating how this drug is handled by the body i.e. absorption and excretion) of an oral tablet formulation intended to be used in future patient studies. The PK of the new oral tablet formulation will be assessed in relation to the oral solution used in previous studies. The effect of food on the PK of the oral tablet formulation will also be assessed. We will collect and store blood samples for potential future exploratory research on intermediary metabolism and on AZD8329. The study will be carried out in healthy male subjects aged 18 to 45 years. It is planned to dose 15 volunteers in this study. The study will consist of five visits. Visit 1 will be the screening visit, Visit 2, 3 and 4 will be the dosing visits and Visit 5 will be the follow-up visit. Visit 2, 3 and 4 involves in house stay of 3 nights and 4 days followed by two day visits. The study centre will be Quintiles Drug Research Unit at Guy’s Hospital in London, United Kingdom. Information from this study will be important for further formulation development.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
10/IEC05/31
Date of REC Opinion
8 Nov 2010
REC opinion
Further Information Favourable Opinion