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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
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This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD6765 75 mg | Experimental |
| |
| AZD6765 150 mg | Experimental |
| |
| Ketamine 0.5 mg/kg | Active Comparator |
| |
| 125 mL sterile NaCl 0.9% | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 | Drug | 75 mg |
| |
| AZD6765 |
| Measure | Description | Time Frame |
|---|---|---|
| qEEG assessed through the gamma bands | Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albena Patroneva, MD | AstraZeneca | Study Director |
| Francine Santoro | Forenap | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Rouffach | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24126931 | Derived | 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. |
| Label | URL |
|---|---|
| D2285M00008 Clinical Study Report Synopsis | View source |
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| ID | Term |
|---|---|
| C585977 | AZD6765 |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
150 mg |
|
| Ketamine | Drug | 0.5 mg/kg |
|
| Placebo | Drug | 125 mL sterile NaCl 0.9% |
|
| 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 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |