The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function

Evotec

Status and phase: Completed; Phase 1

Conditions: Human Volunteers

Treatments: Drug: placebo; Drug: EVT 101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00526968

EVT 101/1002

EudraCT No.: 2007-000986-40

Details and patient eligibility

About

The purpose of this study is to investigate the neurophysiological changes following single doses of EVT 101 using fMRI during rest and during cognitive tasks in young healthy male subjects.

Enrollment: 19 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Male volunteers
• Body Mass Index between 19 and 29

Exclusion criteria

• Subjects who received any prescribed medication within 5 half lives or 14 days of the first dose administration whichever is the longer
• Subjects who have received any prescribed CNS medication or any medication known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
• Participation in a clinical trial of an investigational drug within the past 4 months or of a marketed drug within the past 3 months
• History of allergy to NMDA antagonists or other clinically significant drug allergy
• Supine blood pressure and heart rate of higher than 140/90 mmHg and 90 bpm respectively or lower than 80/40 mmHg and 40 bpm
• Consumption of more than 21 units of alcohol per week or history of alcoholism or drug/chemical abuse
• Smokers of more than 5 cigarettes or equivalent per day
• Subjects who cannot complete the neuropsychological test battery
• Any clinically significant health deficit

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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19 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

EVT 101 8 mg capsule

Treatment:

Drug: EVT 101

Drug: EVT 101

2

Experimental group

Description:

EVT 101 15 mg capsule

Treatment:

Drug: EVT 101

Drug: EVT 101

3

Placebo Comparator group

Description:

Matching placebo capsule

Treatment:

Drug: placebo