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AZD6482

Phase 1

Antiplatelet Effect | Small molecule | Other |AstraZeneca PLC|Last Updated: Aug 19, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00853450Bleeding Time Study With AZD6482, Clopidogrel and ASAPHASE1 COMPLETED 28 — — Feb 1, 2009Jul 1, 2009Aug 19, 20091 Sweden
NCT00688714Study to Investigate Safety and Tolerability of a Single Dose of AZD6482PHASE1 COMPLETED 49 — — Jan 1, 2008May 1, 2008Jun 3, 2008 - —
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Study Endpoints
Primary Endpoints
Capillary Bleeding Time (CBT)
Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B
General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables
Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after.
Secondary Endpoints
Effect on bleeding
Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B
Pharmacokinetics
Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion
Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)
Repeatedly during the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALAZD6482 on top of ASA
2ACTIVE_COMPARATORClopidogrel on top of ASA
Interventions
NameTypeDescription
AZD6482DRUGSingle intravenous infusion during a maximum of 5 hours
ClopidogrelDRUGOral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.
ASADRUG75 mg orally once daily during 7 days in each treatment arm
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive * Provision of written informed consent Exclusion Criteria: * Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneury...

Countries:Sweden
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