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AZD9056+ simvastatin

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 2, 2010

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

AZD9056+ simvastatin · 1 trial · 1 indication

Phase 1 1
NCT00736606A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy VolunteersHealthy Volunteers
COMPLETED12 Analytics
PHASE1COMPLETED
A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
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Study Endpoints

Primary Endpoints

PK variables
Frequent sampling occasions during study periods

Secondary Endpoints

Safety variables (adverse events, blood pressure, pulse, safety lab)
During the whole treatment periods
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTALsimvastatin
Period 2EXPERIMENTALsimvastatin + AZD9056

Interventions

NameTypeDescription
simvastatinDRUGOne single dose of 40mg
AZD9056 + simvastatinDRUGAZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7
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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. * Male or female healthy subjects. Females should not be of childbearing potential * Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug...

Countries:Germany
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Frequently asked questions about AZD9056+ simvastatin

What is AZD9056 used for?

AZD9056 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It has been evaluated in clinical trials involving patients with rheumatoid arthritis and in healthy volunteers for safety and drug interaction studies. The drug is not approved and remains in clinical development.

Who makes AZD9056?

AZD9056 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD9056 in rheumatoid arthritis and healthy volunteers.

What phase is AZD9056 in?

AZD9056 has completed a Phase 2b clinical trial in patients with rheumatoid arthritis. It has also completed Phase 1 studies in healthy volunteers. The drug is investigational and has not received regulatory approval.

What clinical trials is AZD9056 in?

AZD9056 has been studied in two completed trials. NCT00520572 was a Phase 2b randomized, double-blind, placebo-controlled study in 385 patients with rheumatoid arthritis. NCT00700986 was a Phase 1 crossover study in 12 healthy male volunteers to investigate retinal function. NCT00736606 was a Phase 1 drug interaction study with simvastatin in healthy volunteers.

Is AZD9056 the same as any other drug?

AZD9056 is the sole name used for this investigational drug in clinical trial records. No alternative names have been associated with it in the available trial information.