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AZD3480

Phase 2

ADHD | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jul 23, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

AZD3480 · 8 trials · 6 indications

Phase 2 3Phase 1 5
NCT00683462An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)ADHD
COMPLETED24 Analytics
NCT00528905Proof of Concept Study of Cognitive Improvement in Patients With SchizophreniaSchizophrenia
COMPLETED400 Analytics
NCT00501111Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's DiseaseAlzheimer Disease
COMPLETED659 Analytics
PHASE2COMPLETED
An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
ADHDUnlock trial analytics
PHASE2COMPLETED
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
SchizophreniaUnlock trial analytics
PHASE2COMPLETED
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The Total Symptoms Scale Score (of ADHD) of the Connors Adult ADHD Rating Scale-Investigator Rating (CAARS-INV).
Visit 1, 2, 3, 4, 5, 8, 9, 10,13, 14 and 15
Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function
Change from baseline to Week 12
Change in ADAS-Cog
assessed after 12 weeks treatment
PK variables
Frequent sampling occasions during
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
11 dECG measurements x 4 (4-way crossover)
Plasma concentration (AUC, Cmax, tmax)
During time period of the PET assessement
The whole brain uptake and regional distribution of radioligand 2-[18F]-F-A85380 following single intravenous (iv) microdose will be assessed (using derived radioactivity measurements).
One on baseline day and one at the drug treatment day

Secondary Endpoints

Clinical Global Impressions Scales (NIMH 1985)
Visit 1, 2, 3, 4, 5, 8, 9, 10, 13, 14,15
CDR computerized cognitive battery
2, 3, 5, 8, 10, 13, 15
CNRU computerized cognitive battery
2, 3, 5, 8, 10, 13, 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR -
2EXPERIMENTAL -
3EXPERIMENTAL -
4ACTIVE_COMPARATORPlacebo during 5 days, active day 6

Interventions

NameTypeDescription
PlaceboDRUG -
AZD3480DRUGCapsules 5 mg/day (once a day) for 2 weeks
DonepezilDRUG -
AripiprazoleDRUGsingle dose on day 5
MoxifloxacinDRUGCapsule(encapsulated), oral, single dose
2-[18F]-F-A85380RADIATIONSingle dose, IV
Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)DRUGCocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix
WarfarinDRUGWarfarin: single dose on day 6
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Confirmed diagnosis of DSM-IV ADHD * Score of equal or more than 2 on at least six of nine items in at least one of the subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV) * Score of equal or more than 4 (at least moderate severity) on the Clinical Global Impressions...

Countries:United StatesCanadaAustriaBelgiumBulgariaCzechiaGermanyRomaniaRussiaSpainUnited KingdomSweden
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Competitive Landscape -ADHD 3 trials

CompanyTickerTrialsLead PhaseDrugs
Supernus Pharmaceuticals, Inc.SUPN1PHASE3SPN-812
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Frequently asked questions about AZD3480

What is AZD3480 used for?

AZD3480 is an investigational small molecule being studied for use in psychiatry, specifically for conditions including schizophrenia, attention-deficit/hyperactivity disorder (ADHD), and Alzheimer's disease. It has been evaluated in clinical trials for cognitive improvement in schizophrenia and for the treatment of adult ADHD.

Who makes AZD3480?

AZD3480 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials of this investigational drug.

What phase is AZD3480 in?

AZD3480 is in Phase 2 clinical development. It has completed Phase 2 trials for schizophrenia and ADHD, as well as Phase 1 drug interaction studies. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AZD3480 in?

AZD3480 has completed several clinical trials, including NCT00528905, a Phase 2 proof-of-concept study in schizophrenia with 400 participants, and NCT00683462, a Phase 2 exploratory trial in adult ADHD with 24 participants. Phase 1 drug interaction studies include NCT00689559 and NCT00689637.

Is AZD3480 the same as TC-1734?

Yes, AZD3480 is also known as TC-1734. In clinical trial NCT00683462, the drug is referred to as AZD3480 (TC-1734), indicating that these names refer to the same investigational compound.