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

NCT ID: NCT01130909

Last Updated: 2014-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-01-31

Brief Summary

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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

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD6765 75 mg

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

75 mg

AZD6765 150 mg

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

150 mg

Ketamine 0.5 mg/kg

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

0.5 mg/kg

125 mL sterile NaCl 0.9%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

125 mL sterile NaCl 0.9%

Interventions

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AZD6765

75 mg

Intervention Type DRUG

AZD6765

150 mg

Intervention Type DRUG

Ketamine

0.5 mg/kg

Intervention Type DRUG

Placebo

125 mL sterile NaCl 0.9%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albena Patroneva, MD

Role: STUDY_DIRECTOR

AstraZeneca

Francine Santoro

Role: PRINCIPAL_INVESTIGATOR

Forenap

Locations

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Research Site

Rouffach, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 24126931 (View on PubMed)

Related Links

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Other Identifiers

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D2285M00008

Identifier Type: -

Identifier Source: org_study_id

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