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AZD6482

Phase 1

Antiplatelet Effect | Small molecule | Other |AstraZeneca PLC|Trials Updated: Aug 19, 2009

AZD6482 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Jun 2008

AZD6482 target and mechanism

Molecular targetPIK3R1, PIK3CB, PIK3CG, PIK3CA, PIK3R2, PIK3CD
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment77

FDA Designations

No designations recorded

AZD6482 clinical trials

AZD6482 · 2 trials · 1 indication

Phase 1 2
NCT00853450Bleeding Time Study With AZD6482, Clopidogrel and ASAAntiplatelet Effect
COMPLETED28 Analytics
NCT00688714Study to Investigate Safety and Tolerability of a Single Dose of AZD6482Antiplatelet Effect
COMPLETED49 Analytics
PHASE1COMPLETED
Bleeding Time Study With AZD6482, Clopidogrel and ASA
Antiplatelet EffectUnlock trial analytics
PHASE1COMPLETED
Study to Investigate Safety and Tolerability of a Single Dose of AZD6482
Antiplatelet EffectUnlock trial analytics

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 to 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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Frequently asked questions about AZD6482

What is AZD6482?

AZD6482 is an investigational small molecule developed by AstraZeneca PLC for antiplatelet effect. It is a PI3K inhibitor that has been studied in Phase 1 clinical trials in healthy male volunteers. It is not approved for any indication and remains in clinical development.

What does AZD6482 target?

AZD6482 targets phosphoinositide 3-kinase (PI3K) subunits, specifically PIK3R1, PIK3CB, PIK3CG, PIK3CA, PIK3R2, and PIK3CD. It acts as an inhibitor of these targets. This mechanism is being explored for its antiplatelet effect, which relates to how platelets activate and aggregate.

Who makes AZD6482?

AZD6482 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical trials investigating this compound. No other developer or partner is identified for this asset.

What phase is AZD6482 in?

AZD6482 is in Phase 1 clinical development. Both of its recorded trials are Phase 1 studies and both are completed. There are no active trials. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is AZD6482 in?

AZD6482 has been studied in two completed Phase 1 trials: NCT00853450, a bleeding time study with AZD6482, clopidogrel and ASA conducted in Sweden with 28 participants, and NCT00688714, a safety and tolerability study of a single dose of AZD6482 with 49 participants. Both enrolled healthy male volunteers.

What is AZD6482 used for?

AZD6482 has been studied for antiplatelet effect in Phase 1 trials. The trials evaluated bleeding time and the safety and tolerability of a single dose in healthy male volunteers. It is an investigational agent and is not approved for any therapeutic use.