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ABT-126

Phase 1

Healthy Volunteers | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 3, 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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00959634Pharmacokinetic Study of ABT-126 in Healthy VolunteersPHASE1 COMPLETED 20 — — Aug 1, 2009 -Nov 3, 20101 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)
One day before dosing through day of last dose and up to 6 days after last dose
ABT-126 levels in blood (plasma)
First dose through last dose and up to 192 hours after last dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDose 1 BID
2EXPERIMENTALDose 2 BID
3PLACEBO_COMPARATORPlacebo BID
Interventions
NameTypeDescription
ABT-126DRUGDose administered twice daily on Study Days 1-10
PlaceboDRUGDose administered twice daily on Study Days 1-10
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects between 18 and 50 years of age * If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) * If male, subject must be surgically sterile (vasectomy) o...

Countries:United States
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