Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects
December 8, 2010 updated by: AstraZeneca
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
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 Overview
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Stockholm, Sweden
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1
Oral solution.
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Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
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Placebo Comparator: 2
Oral solution
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Administered orally as a solution once per day on day 1, and then day 3 through to day 12.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
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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.
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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.
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PK sampling taken at defined timepoints during residential period and follow-up.
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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.
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Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Fransson, MD, AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden
- Study Chair: Lars Stahle, MD, PhD, AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
May 22, 2008
First Submitted That Met QC Criteria
May 23, 2008
First Posted (Estimate)
May 26, 2008
Study Record Updates
Last Update Posted (Estimate)
December 10, 2010
Last Update Submitted That Met QC Criteria
December 8, 2010
Last Verified
December 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D0475C00002
- EudractCT 2007-005524-33
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.