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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: AZD2066; Drug: Placebo

• Registration Number: NCT00684502
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD2066	Oral solution.
2	Placebo	Oral solution

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Stockholm, Sweden