Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: AZD2066
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed informed consent Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG. Exclusion Criteria: History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator. History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder. Intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of study drug.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Oral solution. | Drug: AZD2066<br>* Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.<br>|
| Placebo Comparator: 2<br>Oral solution | Drug: Placebo<br>* Administered orally as a solution once per day on day 1, and then day 3 through to day 12.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD2066 by assessment of adverse events |  | 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. | 
| Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites). |  | PK sampling taken at defined timepoints during residential period and follow-up. | 
| Investigate CNS effects of AZD2066 |  | Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, tolerability, AZD2066, Pain conditions