The Effects of a Novel NMDA NR2B-Subtype Selective Antago... | NCT00526968

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

NCT00526968

Sponsor

Evotec Neurosciences GmbH

Status

Completed

Last Update Posted

Feb 18, 2008Estimated

Enrollment

19Actual

Phase

Phase 1

Conditions

Human Volunteers

Interventions

EVT 101
EVT 101
placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT No.: 2007-000986-40

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Sep 7, 2007

First Submission Date that Met QC Criteria

Sep 7, 2007

First Posted Date

Sep 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2008

Last Update Posted Date

Feb 18, 2008Estimated

Name	Class
Richmond Pharmacology Limited	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	EVT 101 8 mg capsule	Drug: EVT 101
2	Experimental	EVT 101 15 mg capsule	Drug: EVT 101
3	Placebo Comparator	Matching placebo capsule	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EVT 101	Drug	8 mg capsule, single oral dose	1
EVT 101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks		2-hours post dose
Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo		2-hours post dose
Performance scores in the cognitive tests		2-hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs		Up to 24 hours post dose and 5-7 days post last dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nigel Leigh, BSc MBBS Phd	Department of Clinical Neurosciences, Institute of Psychiatry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Neuroimaging Science, Box 089, Institute of Psychiatry		London		SE5 8AF	United Kingdom