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ABP688

Phase 1

Depression | Small molecule | Psychiatry |Novartis AG|Last Updated: Dec 8, 2020

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
UNCONTROLLED
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01528241Characterize the Regional Distribution of [11C] ABP688 in Brain by Positron Emission Tomography (PET)PHASE1 COMPLETED 42Aug 1, 2008May 1, 2010Dec 8, 20202 United States
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Study Endpoints
Primary Endpoints
Binding of [11C] ABP688 to mGlu5 receptors
Day 1

Binding of \[11C\]ABP688 will be determined using positron emission tomography (PET) for up to 90 minutes

Blood levels of [11C] ABP688
Day 1, up to 60 minutes

Blood samples (up to 19 time points via indwelling catheter) will be collected for the determination of \[11C\] ABP688. Specific times are recorded at the clinical site.

Secondary Endpoints
Difference in [11C]ABP688 binding to mGlu5 receptors
Day 1
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
ABP688EXPERIMENTALElderly MDD patients and demography matched healthy volunteer
Interventions
NameTypeDescription
ABP688DRUGCarbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.
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Eligibility Criteria
Age Range55 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Male and female subjects 55-80 (inclusive) * Subjects in good health At screening: * oral body temperature between 35-37.5C * systolic blood pressure: 90-140 mm Hg * diastolic blood pressure: 50-90 mm Hg * pulse rate: 40-90 bpm * Female subjects of child bearing potential mu...

Countries:United States
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