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ABT-614

Phase 1

Healthy Volunteers | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 2, 2010

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00788801Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the BrainPHASE1 COMPLETED 11Dec 1, 2008 -Nov 2, 20102 Canada
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Study Endpoints
Primary Endpoints
D3 receptor occupancy as estimated by measuring ABT-614 induced changes in [11C]-(+)-PHNO BP
At the approximate Tmax following a single dose of study drug
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
BaselineEXPERIMENTAL -
ABT-614 Low DoseEXPERIMENTAL -
ABT-614 High DoseEXPERIMENTAL -
Interventions
NameTypeDescription
ABT-614DRUGBaseline PET scan with radiotracer only, PET scan with radiotracer and ABT-614 Low Dose or ABT-614 High Dose
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Eligibility Criteria
Age Range18 Years — 40 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Body Mass Index (BMI) is 18 to 26 kg/m2, inclusive 2. A condition of general good physical health based upon the results of a medical history, physical examination, vital signs, laboratory profile, 12-lead electrocardiogram (ECG) Exclusion Criteria: 1. Presence of a metal i...

Countries:Canada
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