A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765
- Registration Number
- NCT01130909
- Lead Sponsor
- AstraZeneca
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description AZD6765 75 mg AZD6765 - Ketamine 0.5 mg/kg Ketamine - 125 mL sterile NaCl 0.9% Placebo - AZD6765 150 mg AZD6765 -
- Primary Outcome Measures
Name Time Method qEEG assessed through the gamma bands Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇫🇷Rouffach, France