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ABT-335

Phase 1

Dyslipidemia, Renal Insufficiency | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Sep 28, 2012

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00585143Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered ConcomitantlyPHASE1 COMPLETED 37Jan 1, 2008Oct 1, 2008Sep 28, 20126 United States
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Study Endpoints
Primary Endpoints
Blood concentrations of the active ingredients and metabolites of ABT-335 and rosuvastatin
Days 1, 8, 9, and 10
Secondary Endpoints
Safety and tolerability of the study drugs
Study duration
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
ABT-335DRUG45 mg once daily for 10 consecutive days
RosuvastatinDRUG10 mg once daily for 10 days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria Body Mass Index (BMI) 19 to 33, inclusive Either normal kidney function, or mild or moderate kidney impairment Exclusion Criteria Use of any medications, vitamins and/or herbal supplements within 2 weeks prior to study drug administration, except those required for management ...

Countries:United States
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