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EVT 101

Phase 2

Undisclosed | Small molecule | Other |Evotec SE|Trials Updated: Feb 18, 2008

EVT 101 development status

Highest phase Phase 2 run by Janssen Research & Development, LLC (NCT01128452)
Phase scored for EVOPhase 1
Registered trials 2 across 2 sponsors since Sep 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

EVT 101 clinical trials

EVT 101 · 1 trial · 1 indication

Phase 1 1
NCT00526968The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain FunctionHuman Volunteers
COMPLETED19 Analytics
PHASE1COMPLETED
The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function
Human VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Safety, tolerability, adverse events, safety laboratory tests, ECG, vital signs
Up to 24 hours post dose and 5-7 days post last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALEVT 101 8 mg capsule
2EXPERIMENTALEVT 101 15 mg capsule
3PLACEBO_COMPARATORMatching placebo capsule

Interventions

NameTypeDescription
EVT 101DRUG8 mg capsule, single oral dose
placeboDRUGPlacebo capsule, single oral dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 medicatio...

Countries:United Kingdom
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Frequently asked questions about EVT 101

What is EVT 101?

EVT 101 is an investigational small molecule developed by Evotec SE. It is an NMDA NR2B-subtype selective antagonist that has been studied in Phase 1 clinical testing. The compound was evaluated in a completed trial involving healthy male volunteers in the United Kingdom.

What does EVT 101 target?

EVT 101 targets the NMDA receptor, specifically the NR2B subtype. It acts as a selective antagonist at this receptor. This mechanism was studied in a Phase 1 trial titled "The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function."

Who makes EVT 101?

EVT 101 is developed by Evotec SE, a company listed under the ticker EVO. Evotec is the sponsor of the clinical program for this investigational compound.

What phase is EVT 101 in?

EVT 101 is in Phase 1 clinical development. It has not been approved by the FDA or any regulatory agency. The only recorded trial for EVT 101 is a completed Phase 1 study.

What clinical trials is EVT 101 in?

EVT 101 has been studied in one clinical trial: NCT00526968, titled "The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function." This Phase 1 trial was completed and enrolled 19 healthy male volunteers in the United Kingdom.

What is EVT 101 used for?

EVT 101 is not approved for any indication. It is an investigational drug that has been tested in healthy volunteers to study its effects on brain function. No specific disease indication has been disclosed for this compound.