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

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ClinicalTrials.gov Identifier: NCT01130909
Recruitment Status : 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)
First Posted : May 26, 2010
Last Update Posted : October 13, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE May 19, 2010
First Posted Date  ICMJE May 26, 2010
Last Update Posted Date October 13, 2014
Study Start Date  ICMJE May 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
qEEG assessed through the gamma bands [ Time Frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
  • 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 ]
  • Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus. [ Time Frame: 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 [ Time Frame: Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Blinded, Four-Way Crossover in Healthy Subjects to Assess EEG After Administration of Ketamine, Placebo and AZD6765
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: AZD6765
    75 mg
  • Drug: AZD6765
    150 mg
  • Drug: Ketamine
    0.5 mg/kg
  • Drug: Placebo
    125 mL sterile NaCl 0.9%
Study Arms  ICMJE
  • Experimental: AZD6765 75 mg
    Intervention: Drug: AZD6765
  • Experimental: AZD6765 150 mg
    Intervention: Drug: AZD6765
  • Active Comparator: Ketamine 0.5 mg/kg
    Intervention: Drug: Ketamine
  • Placebo Comparator: 125 mL sterile NaCl 0.9%
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 14, 2011)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2010)
19
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 30 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01130909
Other Study ID Numbers  ICMJE D2285M00008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Albena Patroneva, MD AstraZeneca
Principal Investigator: Francine Santoro Forenap
PRS Account AstraZeneca
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP