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

Healthy Clinical Trial

— AZD6765 EEG  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01130909
• Other study ID #: D2285M00008
• Status: Terminated
• Phase: Phase 1
• First received: May 19, 2010
• Last updated: October 10, 2014
• Start date: May 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD6765
75 mg
• AZD6765
150 mg
• Ketamine
0.5 mg/kg
• Placebo
125 mL sterile NaCl 0.9%

Locations

Country	Name	City	State
France	Research Site	Rouffach

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qEEG assessed through the gamma bands		Day 1 of each treatment period at Predose, 0.25h, 1h, 1.25h, 3h and 8h	No
Secondary	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	No
Secondary	Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.		Day 1 of each treatment period at Predose, 1h, 3h, and 8h	No
Secondary	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	No

External Links

•   D2285M00008 Clinical Study Report Synopsis