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Completed

NCT Number: NCT00684502

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD2066

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 26, 2008
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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