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ABT-436

Phase 1

Healthy | 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01050127A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy AdultsPHASE1 COMPLETED 36Dec 1, 2009 -Nov 3, 20101 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)
Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)
Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)
Day -1 through Day 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low dose ABT-436EXPERIMENTALABT-436 or placebo administered once daily for 7 days.
Mid Dose ABT-436EXPERIMENTALABT-436 or placebo administered once daily for 7 days.
High Dose ABT-436EXPERIMENTALABT-436 or placebo administered once daily for 14 days.
Interventions
NameTypeDescription
ABT-436DRUGSee Arm Description for details.
PlaceboDRUGSee Arm Description for details.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age is between 18 and 55 years, inclusive. 2. If female, subject must be postmenopausal for at least two years or surgically sterile. 3. Females must have negative results for pregnancy tests prior to study drug administration. 4. If male, subject must be surgically sterile o...

Countries:United States
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