Pain
Conditions
Keywords
Safety, tolerability, AZD2066, Pain conditions
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.
Interventions
DRUGAZD2066
Oral solution administered orally once per day on day 1, and then day 3 through to day 12. Specific dose depends on dose panel.
DRUGPlacebo
Administered orally as a solution once per day on day 1, and then day 3 through to day 12.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG | 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
| Measure | Time frame |
|---|---|
| Safety and tolerability of AZD2066 by assessment of adverse events | 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). | PK sampling taken at defined timepoints during residential period and follow-up. |
| Investigate CNS effects of AZD2066 | Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes. |
Countries
Sweden
Outcome results
None listed