Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Detailed Description
-----------------
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Furthermore, the study has been expanded to include two additional panels with increment of dose during the multiple dosing period (12 days) in order to obtain sufficient information on safety and tolerability of multiple dosing of AZD2066 in Japanese subjects at higher levels of exposure. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Official Title
-----------------
A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Oral Doses of AZD2066 in Japanese Healthy Male Subjects

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed informed consent Healthy Japanese males as judged by the investigator 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) within first 2 weeks before first administration of study drug.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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>4 dose panels receiving a specified volume of AZD2066 oral solution once daily for 11 days | Drug: AZD2066<br>* Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16. Specific dose depends on dose panel.<br>|
| Placebo Comparator: 2<br>Included in each dose panel | Drug: Placebo<br>* Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. For the fifth and sixth panels, oral solution administered once per day on day 1, and then day 5 through to day 16.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability 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 |
| --- | --- | --- |
| Investigate pharmacokinetic profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 in Japanese healthy male subjects |  | Blood sampling at defined timepoints during residential period and follow-up | 
| Investigate CNS effects of AZD2066 in Japanese healthy male subjects |  | 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, pharmacokinetics, AZD2066, Japanese