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

Ketamine

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.

Intervention / Treatment

  • AZD6765 (DRUG)
    150 mg
  • Ketamine (DRUG)
    0.5 mg/kg
  • Placebo (DRUG)
    125 mL sterile NaCl 0.9%

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 30 Years to 45 Years
    Enrollment: 36 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: May 01, 2010
    Primary Completion: Jan 01, 2011 ACTUAL
    Completion Date: Jan 01, 2011 ACTUAL
    Study First Posted: May 26, 2010 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 10, 2014

    Sponsors / Collaborators

    Lead Sponsor: AstraZeneca
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Rouffach, Grand Est, France

    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

    Participant Groups

    • No description provided

    • No description provided

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: Male
    Minimum Age: 30
    Maximum Age: 45
    Age Groups: Adult
    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

    Primary Outcomes
    • qEEG assessed through the gamma bands Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
    Secondary Outcomes
    • 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

    More Details

    NCT Number: NCT01130909
    Acronym: AZD6765 EEG
    Other IDs: D2285M00008
    Study URL: https://clinicaltrials.gov/study/NCT01130909
    Last updated: Sep 29, 2023