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ABT-384

Phase 1

Healthy | Small molecule | Other |Abbott Laboratories|Last Updated: Dec 14, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01009216A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal FluidPHASE1 COMPLETED 12Oct 1, 2009Nov 1, 2010Dec 14, 20101 United States
NCT00968422A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-384 in Elderly SubjectsPHASE1 COMPLETED 28Aug 1, 2009 -Nov 3, 20101 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Days -1 through 9
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)
Days 1, 4 through 9
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABT-384EXPERIMENTAL -
Low dose ABT-384EXPERIMENTAL -
Mid dose ABT-384EXPERIMENTAL -
High dose ABT-384EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ABT-384DRUGDoses will be administered daily for 5 days.
Matching placebo to ABT-384DRUGDoses will be administered daily for 21 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age is between 18 and 55 years * Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: * Use of protocol-prohibited medications within 2 weeks pr...

Countries:United States
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