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TerminatedNCT01130909AZD6765 EEGUpdated Oct 13, 2014

A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765

A Phase 1 interventional study of AZD6765 and AZD6765 in Healthy, sponsored by AstraZeneca. Terminated at 1 site in France. Open to male participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-13.

Sponsored by AstraZeneca · Phase 1, Interventional, and Basic science

Why this study was terminated
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
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
30 Years to 45 Years
Sex
Male
01

Study 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.

Read the 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

02

Conditions studied

  • Healthy

Keywords

  • Healthy
  • Effect of a single dose on gamma-band qEEG
03

In context

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • BMI 18-30 Non-smoker for at least 4 weeks

Exclusion criteria

Exclusion Criteria:

  • Any clinically relevant acute or chronic disease
  • History of substance abuse Hypersensitivity to ketamine
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    AZD6765 75 mg

    Drug: AZD6765

  • Experimental
    AZD6765 150 mg

    Drug: AZD6765

  • Active comparator
    Ketamine 0.5 mg/kg

    Drug: Ketamine

  • Placebo comparator
    125 mL sterile NaCl 0.9%

    Drug: Placebo

Interventions

  • DrugAZD6765

    75 mg

  • DrugAZD6765

    150 mg

  • DrugKetamine

    0.5 mg/kg

  • DrugPlacebo

    125 mL sterile NaCl 0.9%

06

What researchers measure

Primary outcomes

  1. qEEG assessed through the gamma bands

    Time frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h

Secondary outcomes

  1. Pupil Size - to assess the relationship between qEEG and pupil size

    Time frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h, and 8h

  2. Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.

    Time frame: Day 1 of each treatment period at Predose, 1h, 3h, and 8h

  3. Bond/Lader scales and eVAS - to assess the subject's alertness, calmness and contentment

    Time frame: Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h

07

Study locations

1 site
  • Research Site
    Rouffach, France
08

References and documents

Publications

  • 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. PubMed 24126931 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01130909
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 26, 2010
Start date
May 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Oct 13, 2014

Study contacts

Albena Patroneva, MD
study director · AstraZeneca
Francine Santoro
principal investigator · Forenap

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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