Clinical trial NCT00684502: Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Safety
tolerability
AZD2066
Pain conditions
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG
timeFrame: 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:
measure: Safety and tolerability of AZD2066 by assessment of adverse events
timeFrame: 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.
measure: Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites).
timeFrame: PK sampling taken at defined timepoints during residential period and follow-up.
measure: Investigate CNS effects of AZD2066
timeFrame: Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D SödertäljeMedical Science, CPU C2:84Karolinska University Hospital HuddingeSE-141 86 Stockholm, Sweden
name: Bo Fransson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Södertälje Medical Science S-151 85 Södertälje Sweden
name: Lars Stahle, MD, PhD
role: STUDY_CHAIR
References: