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EVT 101

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00526968The Effects of a Novel NMDA NR2B-Subtype Selective Antagonist, EVT 101, on Brain FunctionPHASE1 COMPLETED 19 — — Sep 1, 2007Dec 1, 2007Feb 18, 20081 United Kingdom
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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 — 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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