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

AstraZeneca110 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

110

Conditions

Pain

Interventions

AZD2066DRUG

Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.

PlaceboDRUG

Administered orally as a solution once per day on day 1, and then day 3 through to day 12.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Stockholm, Sweden

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

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.

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.

Data from ClinicalTrials.gov

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