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

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: AZD2066 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	January 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Oral solution.	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. Other Name: AZD2066
Placebo Comparator: 2 Oral solution	Drug: Placebo Administered orally as a solution once per day on day 1, and then day 3 through to day 12.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684502

Locations

Sweden
Research Site
Stockholm, Sweden

Sponsors and Collaborators

AstraZeneca

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

More Information

No publications provided

Responsible Party:	Rolf Karlsten, M.D., Medical Science Director, Emerging Neuroscience, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00684502 History of Changes
Other Study ID Numbers:	D0475C00002, EudractCT 2007-005524-33
Study First Received:	May 22, 2008
Last Updated:	December 8, 2010
Health Authority:	Sweden: Medical Products Agency Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Safety
tolerability
AZD2066
Pain conditions

ClinicalTrials.gov processed this record on June 13, 2013