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AZD9056 + simvastatin

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 2, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00736606A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy VolunteersPHASE1 COMPLETED 12Aug 1, 2008Sep 1, 2008Dec 2, 20101 Germany
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Study Endpoints
Primary Endpoints
PK variables
Frequent sampling occasions during study periods
Secondary Endpoints
Safety variables (adverse events, blood pressure, pulse, safety lab)
During the whole treatment periods
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Period 1EXPERIMENTALsimvastatin
Period 2EXPERIMENTALsimvastatin + AZD9056
Interventions
NameTypeDescription
simvastatinDRUGOne single dose of 40mg
AZD9056 + simvastatinDRUGAZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * Male or female healthy subjects. Females should not be of childbearing potential * Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug...

Countries:Germany
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