Human VolunteersPhase 1NCT00526968
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
A Phase 1 study testing EVT 101 in people with Human Volunteers, run by Evotec Neurosciences GmbH at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Volunteers
- What is being tested?
- EVT 101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Male volunteers
- Body Mass Index between 19 and 29
Who cannot join
- 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
Show all 9Show fewer
- Smokers of more than 5 cigarettes or equivalent per day
- Subjects who cannot complete the neuropsychological test battery
- Any clinically significant health deficit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Neuroimaging Science, Box 089, Institute of Psychiatry
London, SE5 8AF
About this study
Official title: A Double Blind, Placebo Controlled Study to Investigate the Role of NMDA Receptor NR2B Subunit Selective Antagonism on Cognitive Functions and Neurophysiology in Healthy Subjects as Measured With MRI
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.
- Conditions
- Human Volunteers
- Being tested
- EVT 101, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT 101Drug
8 mg capsule, single oral dose
EVT 101Drug
15 mg capsule, single oral dose
placeboDrug
Placebo capsule, single oral dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | EVT 101 8 mg capsule Receives: Drug: EVT 101 |
| 2 | Experimental | EVT 101 15 mg capsule Receives: Drug: EVT 101 |
| 3 | Placebo comparator | Matching placebo capsule Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
Measured: 2-hours post dose
Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo
Measured: 2-hours post dose
Performance scores in the cognitive tests
Measured: 2-hours post dose
Secondary outcomes (1)
Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs
Measured: Up to 24 hours post dose and 5-7 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evotec Neurosciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Investigators
- Nigel Leigh, BSc MBBS Phd, Principal investigator, Department of Clinical Neurosciences, Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526968
- Sponsor's protocol ID
- EVT 101/1002
- Other IDs
- EudraCT No.: 2007-000986-40
- Status last verified
- Feb 2008
- First submitted
- 7 Sep 2007
- Last updated
- 18 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled Study to Investigate the Role of NMDA Receptor NR2B Subunit Selective Antagonism on Cognitive Functions and Neurophysiology in Healthy Subjects as Measured With MRI
- ClinicalTrials.gov ID
- NCT00526968
- Acronym / sponsor ID
- EVT 101/1002
- Conditions
- Human Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Evotec Neurosciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Richmond Pharmacology Limited
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 10 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: EVT 101EVT 101 8 mg capsule |
| 2 | Experimental | Drug: EVT 101EVT 101 15 mg capsule |
| 3 | Placebo comparator | Drug: placeboMatching placebo capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Male volunteers
- Body Mass Index between 19 and 29
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVT 1018 mg capsule, single oral dose | Drug | 1 |
| EVT 10115 mg capsule, single oral dose | Drug | 2 |
| placeboPlacebo capsule, single oral dose | Drug | 3 |
Primary outcome
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks
Time frame: 2-hours post dose
Change in regional cerebral blood flow (determined with ASL-MRI)after drug compared with placebo
Time frame: 2-hours post dose
Performance scores in the cognitive tests
Time frame: 2-hours post dose
1 secondary outcome
Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs
Time frame: Up to 24 hours post dose and 5-7 days post last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nigel Leigh, BSc MBBS Phd principal investigator
Department of Clinical Neurosciences, Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EVT 101 in people with Human Volunteers, run by Evotec Neurosciences GmbH at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fMRI BOLD signal under baseline conditions and during activation by cognitive tasks (time frame: 2-hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2008.