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

October 10, 2014 updated by: AstraZeneca

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

This study will provide data to support preclinical to clinical translation by aligning preclinical and clinical efficacy assay with dose dependent changes in EEG.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouffach, France
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZD6765 75 mg
Drug: AZD6765
75 mg
Drug: AZD6765
150 mg
Experimental: AZD6765 150 mg
Drug: AZD6765
75 mg
Drug: AZD6765
150 mg
Active Comparator: Ketamine 0.5 mg/kg
Drug: Ketamine
0.5 mg/kg
Placebo Comparator: 125 mL sterile NaCl 0.9%
Drug: Placebo
125 mL sterile NaCl 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
qEEG assessed through the gamma bands
Time Frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h
Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
Day 1 of each treatment period at Predose, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, and 8h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Albena Patroneva, MD, AstraZeneca
  • Principal Investigator: Francine Santoro, FORENAP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

October 13, 2014

Last Update Submitted That Met QC Criteria

October 10, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2285M00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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