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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: AZD2066
    • Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
  • Drug: Placebo
    • Administered orally as a solution once per day on day 1, and then day 3 through to day 12.

Arms, Groups and Cohorts

  • Experimental: 1
    • Oral solution.
  • Placebo Comparator: 2
    • Oral solution

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Rolf Karlsten, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals
  • Overall Official(s)
    • Bo Fransson, MD, Principal Investigator, AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden
    • Lars Stahle, MD, PhD, Study Chair, AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden

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