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SLV354

Phase 1

Schizophrenia | Small molecule | Psychiatry |Abbott Laboratories|Last Updated: Sep 18, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01545310A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With SchizophreniaPHASE1 COMPLETED 18May 1, 2011Jul 1, 2012Sep 18, 20121 United States
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Study Endpoints
Primary Endpoints
Brain receptor occupancy
Study Day -1

5-HT6 receptor occupancy and the relationship between SLV354 plasma concentrations and receptor occupancy

Secondary Endpoints
Pharmacokinetic profile
Up through Study Day 4
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Group 1 (healthy), Group 2 (schizophrenia)EXPERIMENTAL -
Interventions
NameTypeDescription
SLV354DRUGOne dose of ABT-354
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria 1. Male, age between 18 and 55 years, inclusive. 2. Body Mass Index 18 to 30 (healthy) and 18 to 38 (schizophrenia). 3. A condition of general good physical health. 4. Schizophrenia subjects must have a diagnosis of schizophrenia based on Diagnostic and Statistical Manual of Ment...

Countries:United States
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