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

This study has been 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)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01130909
First received: May 19, 2010
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: AZD6765
Drug: Ketamine
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • qEEG assessed through the gamma bands [ Time Frame: Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus. [ Time Frame: Day 1 of each treatment period at Predose, 1h, 3h, and 8h ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: May 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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

  Eligibility

Ages Eligible for Study:   30 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130909

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01130909     History of Changes
Other Study ID Numbers: D2285M00008
Study First Received: May 19, 2010
Last Updated: December 14, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on June 18, 2013