We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD6765 Drug: Ketamine Drug: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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 Start Date : May 2010
Primary Completion Date : January 2011
Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AZD6765 75 mg Drug: AZD6765
75 mg
Experimental: AZD6765 150 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%



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130909


Locations
France
Research Site
Rouffach, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Albena Patroneva, MD AstraZeneca
Principal Investigator: Francine Santoro Forenap

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01130909     History of Changes
Other Study ID Numbers: D2285M00008
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Keywords provided by AstraZeneca:
Healthy
Effect of a single dose on gamma-band qEEG

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action