Study Stopped
The benefit of halting the study to analyze the available data outweighs the benefit of delaying the analysis to include data from remaining treatment periods
A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765
AZD6765 EEG
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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2010
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 19, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedOctober 13, 2014
October 1, 2014
8 months
May 19, 2010
October 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
qEEG assessed through the gamma bands
Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
Secondary Outcomes (3)
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
Study Arms (4)
AZD6765 75 mg
EXPERIMENTALAZD6765 150 mg
EXPERIMENTALKetamine 0.5 mg/kg
ACTIVE COMPARATOR125 mL sterile NaCl 0.9%
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- BMI 18-30 Non-smoker for at least 4 weeks
You may not qualify if:
- Any clinically relevant acute or chronic disease
- History of substance abuse Hypersensitivity to ketamine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Rouffach, France
Related Publications (1)
Sanacora G, Smith MA, Pathak S, Su HL, Boeijinga PH, McCarthy DJ, Quirk MC. Lanicemine: a low-trapping NMDA channel blocker produces sustained antidepressant efficacy with minimal psychotomimetic adverse effects. Mol Psychiatry. 2014 Sep;19(9):978-85. doi: 10.1038/mp.2013.130. Epub 2013 Oct 15.
PMID: 24126931DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Albena Patroneva, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Francine Santoro
Forenap
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2010
First Posted
May 26, 2010
Study Start
May 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
October 13, 2014
Record last verified: 2014-10