Healthy
Conditions
Keywords
Healthy, Effect of a single dose on gamma-band qEEG
Brief summary
This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.
Detailed description
A Phase I, Randomized, Double-Blind, Four-way Cross-over Study in Healthy Subjects to Assess Quantitative Electroencephalography (qEEG) parameters after the administration of ketamine, two doses of AZD6765 and Placebo
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI 18-30 Non-smoker for at least 4 weeks
Exclusion criteria
* Any clinically relevant acute or chronic disease * History of substance abuse Hypersensitivity to ketamine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| qEEG assessed through the gamma bands | Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h |
Secondary
| Measure | Time frame |
|---|---|
| Pupil Size - to assess the relationship between qEEG and pupil size | Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h |
| Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus. | Day 1 of each treatment period at Predose, 1h, 3h, and 8h |
| Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment | Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h |
Countries
France
Outcome results
None listed