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EVT 101

Phase 1

Human Volunteers | Small molecule | Other |Evotec SE|Last Updated: Feb 18, 2008

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

Clinical trial landscape

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 used for?

EVT 101 is an investigational small molecule being studied in human volunteers. It is a novel NMDA NR2B-subtype selective antagonist. The completed Phase 1 trial evaluated its effects on brain function in healthy male volunteers aged 18 years and older in the United Kingdom.

What does EVT 101 target?

EVT 101 targets the NR2B subtype of the NMDA receptor. It is described as a novel NMDA NR2B-subtype selective antagonist, meaning it selectively blocks this specific receptor subtype. This mechanism was studied in a Phase 1 trial assessing its effects on brain function.

Who makes EVT 101?

EVT 101 is being developed by Evotec SE, a biopharmaceutical company listed on the stock exchange under the ticker EVO. The company conducted a Phase 1 clinical trial of EVT 101 in the United Kingdom.

What phase is EVT 101 in?

EVT 101 is in Phase 1 clinical development. The single trial listed for EVT 101 was a Phase 1 study that has been completed. EVT 101 is an investigational drug and is not approved for any indication.

What clinical trials is EVT 101 in?

EVT 101 has one completed clinical trial, registered as NCT00526968. The trial was titled "The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain Function" and enrolled 19 healthy male volunteers in the United Kingdom. It was a randomized, double-blind, placebo-controlled study.

Is EVT 101 the same as other NMDA antagonists?

EVT 101 is a specific NMDA NR2B-subtype selective antagonist. It is not identified as the same as any other drug in the available information. Its selectivity for the NR2B subtype distinguishes it from non-selective NMDA receptor antagonists.