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

Phase 1TerminatedNCT01130909

AstraZeneca36 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

AZD6765DRUG

75 mg

AZD6765DRUG

150 mg

KetamineDRUG

0.5 mg/kg

PlaceboDRUG

Eligibility

Sex: MALEMin age: 30 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Rouffach, France

Outcomes

Primary Outcomes

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 Outcomes

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

Electronystagmography - to assess the relationship between qEEG and spontaneous nystagmus.

Time frame: 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

Data from ClinicalTrials.gov

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