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AZD0328

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 29, 2008

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 Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00752830To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328PHASE1 COMPLETED 14Sep 1, 2008Oct 1, 2008Oct 29, 20081 Sweden
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Study Endpoints
Primary Endpoints
PK variables
Several PK samples during the study days
Secondary Endpoints
Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)
During the whole treatment period
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD0328 administration during fasting condition
2EXPERIMENTALAZD0328 administration after food intake
Interventions
NameTypeDescription
AZD0328DRUGOral capsule, single dose
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male Caucasian subjects. * Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator. * Signed informed consent form Exclusion Criteria: * History of clinically significant cardio or cerebrovascular, pulmonary, ...

Countries:Sweden
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