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AZD5672

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |AstraZeneca PLC|Last Updated: Oct 3, 2011

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment465

FDA Designations

No designations recorded

Clinical trial landscape

AZD5672 · 8 trials · 4 indications

Phase 2 1Phase 1 7
NCT00713544A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED373 Analytics
PHASE2COMPLETED
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

American College of Rheumatology 20 Response (ACR20)
12 weeks

The number of participants with greater to or equal to 20% improvement in the ACR composite score (a measure of RA symptoms including: joint swelling and tenderness; patient's assessment of pain, disease activity and physical function; physician's assessment of disease activity; and CRP) after 12 Weeks' treatment.

Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
Up to 24 hours postdose
Relative bioavailability of AZD5672 using PK variables AUC ss and C max ss
Frequent sampling occasions during study periods, with intensive sampling occurring on days 7,14,21 and 28
PK variables
Frequent sampling occasions during study periods
total radioactivity in plasma, whole blood, faeces and urine.
Pre-dose, post dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2, 3, 4, 6, 9, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240h
Additional metabolite identification
0.5h, 3h, 6h, 12h, 24h

Secondary Endpoints

American College of Rheumatology 50 Response (ACR50)
12 weeks
American College of Rheumatology 70 Response (ACR70)
12 weeks
Disease Activity Score (Based on 28 Joint Count) (DAS28)
Baseline to 12 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2EXPERIMENTAL20mg
3EXPERIMENTAL50mg
4EXPERIMENTAL100mg
5EXPERIMENTAL150mg
6PLACEBO_COMPARATOR -
AEXPERIMENTAL600mg AZD5672 + Moxifloxacin placebo
BEXPERIMENTAL100mg AZD5672 + Moxifloxacin placebo
CACTIVE_COMPARATORAZD5672 placebo + Moxifloxacin 400mg
DPLACEBO_COMPARATORAZD5672 placebo + Moxifloxacin placebo

Interventions

NameTypeDescription
AZD5672DRUG20 mg oral, once daily
EtanerceptDRUG50 mg, subcutaneous injection, weekly
PlaceboDRUGplacebo, oral, once daily
MoxifloxacinDRUG1 x 400mg capsule, oral, single dose
atorvastatinDRUGone single dose of 40 mg on day 10
DigoxinDRUG0.5mg dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites49

Inclusion Criteria: * Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6 tender/painful joints, and either have (blood tests) elevated erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). * At least one of the following: documented history of positive rheumatoid f...

Countries:BulgariaColombiaCzechiaHungaryItalyLatviaMaltaPolandRomaniaRussiaSerbiaSlovakiaSouth AfricaUkraineUnited KingdomGermany
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Frequently asked questions about AZD5672

What is AZD5672 used for?

AZD5672 is an investigational small molecule being studied for use in renal impairment, rheumatoid arthritis, and healthy volunteers. It has completed four Phase 1 clinical trials with a total enrollment of 465 participants. The drug is not approved and remains in clinical development.

Who makes AZD5672?

AZD5672 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored all four completed Phase 1 clinical trials of AZD5672, which involved healthy volunteers and subjects with renal impairment or rheumatoid arthritis.

What phase is AZD5672 in?

AZD5672 is in Phase 1 clinical development. All four trials of AZD5672 are Phase 1 studies and have been completed. The drug is investigational and has not received FDA approval, as it is still in the early stages of clinical testing.

What clinical trials has AZD5672 been in?

AZD5672 has been studied in four completed Phase 1 trials: NCT00711074, a mass balance and metabolic profiling study in healthy male volunteers; NCT00715702, a safety study in renally impaired subjects; NCT00871767, a bioavailability study; and NCT00887770, a study on cardiac electrical conduction. All trials were controlled, randomized, and double-blind.

Is AZD5672 the same as any other drug?

AZD5672 is the sole name used for this investigational drug in its clinical trials. No alternative names have been reported for AZD5672 in the completed Phase 1 studies. The drug is a small molecule developed by AstraZeneca for potential use in renal impairment and rheumatoid arthritis.