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AZD9056 formulation Phase III

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 23, 2009

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00908934AZD9056 Relative Bioavailability StudyPHASE1 COMPLETED 24 — — May 1, 2009Jul 1, 2009Jul 23, 20091 United Kingdom
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Study Endpoints
Primary Endpoints
Relative bioavailability of AZD9056 using PK variables Cmax and AUC
For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Secondary Endpoints
Descriptive PK parameters for AZD9056 using PK variables (tmax, AUC(0-t), t1/2, CL/F and Vz/F)
For each study period, intensive sampling occasions on day 1: half hourly after dosing until 4 hours, then 4,6,8 and 12 hours post dose, with once daily sampling on days 2 to 7
Safety variables (adverse events, safety lab, blood pressure, pulse, ECG)
Frequent sampling occasions throughout the study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL50 or 400 mg AZD9056, Test formulation
2EXPERIMENTAL50 or 400 mg AZD9056, Reference formulation
Interventions
NameTypeDescription
AZD9056 formulation Phase III 50 mg (T)DRUGGiven as 50 mg tablet (T)
AZD9056 formulation Phase IIb 50 mg (R)DRUGGiven as 50 mg tablet (R)
AZD9056 formulation Phase III 200 mg (T)DRUGGiven as 400 mg (2 x 200 mg tablet (T))
AZD9056 formulation Phase IIb 200mg (R)DRUGGiven as 400 mg (2 x 200 mg tablet (R))
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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 * Healthy Volunteers, Females should not be of childbearing potential * BMI between 18 and 30 kg/m2 Exclusion Criteria: * Clinically significant ECG abnormality suggestive of underlying cardiovascular disea...

Countries:United Kingdom
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