Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects
The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects After Oral Multiple Ascending Doses|
- Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG [ Time Frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3 ] [ Designated as safety issue: Yes ]
- Safety and tolerability of AZD2066 by assessment of adverse events [ Time Frame: Non serious adverse events will be collected from the start of Visit 2 until the end of the study. Serious adverse events will be collected from signing of consent until end of study. ] [ Designated as safety issue: Yes ]
- Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites). [ Time Frame: PK sampling taken at defined timepoints during residential period and follow-up. ] [ Designated as safety issue: No ]
- Investigate CNS effects of AZD2066 [ Time Frame: Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
Other Name: AZD2066
Placebo Comparator: 2
Administered orally as a solution once per day on day 1, and then day 3 through to day 12.
|Principal Investigator:||Bo Fransson, MD||AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden|
|Study Chair:||Lars Stahle, MD, PhD||AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden|