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AZD9056 formulation Phase III

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jul 23, 2009

AZD9056 formulation Phase III target and mechanism

Molecular targetP2RX7
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

AZD9056 formulation Phase III clinical trials

AZD9056 formulation Phase III · 1 trial · 1 indication

Phase 1 1
NCT00908934AZD9056 Relative Bioavailability StudyHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
AZD9056 Relative Bioavailability Study
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about AZD9056 formulation Phase III

What is AZD9056 formulation Phase III?

AZD9056 formulation Phase III is an investigational small molecule developed by AstraZeneca PLC. It is a P2RX7 antagonist that has been studied in a Phase 1 relative bioavailability trial in healthy volunteers. The formulation designation refers to a specific version of the drug evaluated in that study.

What does AZD9056 formulation Phase III target?

AZD9056 formulation Phase III targets P2RX7, a purinergic receptor. It acts as an antagonist at this target. The molecular target is P2RX7, and the compound is classified as a small molecule P2RX7 antagonist.

Who is developing AZD9056 formulation Phase III?

AstraZeneca PLC is developing AZD9056 formulation Phase III. The company's ticker symbol is AZN. AstraZeneca is the sponsor of the clinical trial evaluating this drug.

What phase is AZD9056 formulation Phase III in?

AZD9056 formulation Phase III is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The only listed trial is a completed Phase 1 study.

What clinical trials is AZD9056 formulation Phase III in?

AZD9056 formulation Phase III has been studied in one clinical trial: NCT00908934, titled AZD9056 Relative Bioavailability Study. This Phase 1 trial was completed, enrolled 24 healthy volunteers, and was conducted in the United Kingdom. It was randomized and controlled but not double-blind.