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AZD8529

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Nov 1, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment355

FDA Designations

No designations recorded

Clinical trial landscape

AZD8529 · 6 trials · 4 indications

Phase 2 1Phase 1 4Early Phase 1 1
NCT00921804Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia PatientsSchizophrenia
COMPLETED296 Analytics
PHASE2COMPLETED
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
Schizophrenia
NCT00921804296
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Study Endpoints

Primary Endpoints

PANSS Total Score
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Functional magnetic resonance imaging (fMRI)
1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests
1 on Day -1; 1 on Day 1 and on Day 21
To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.
From screening period to follow-up, 42 days (maiximum).
To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
each visit, at least daily, during the study.
To assess the safety and tolerability of single dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
at each visit, at least daily, during the study.
fMRI
3
Ketamine Infusion
3

Secondary Endpoints

PANSS Positive, Negative, and General Psychopathology Subscale Scores
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD8529 40 mg
2PLACEBO_COMPARATORPlacebo
3OTHERRisperidone 4 mg (2mg on Day 1)

Interventions

NameTypeDescription
AZD 8529DRUG40mg oral daily capsule administered as a single dose in the morning for 28 days
RisperidoneDRUG4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529DRUGPlacebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Placebo to match risperidoneDRUGPlacebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
AZD8529DRUG2 capsules by mouth for 3 days
PlaceboDRUGOral
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Patient will need to read, understand and sign an informed consent prior to any study specific procedures * Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry Exclusion Criteria: * Patients will be excluded based on...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Schizophrenia 36 trials

CompanyTickerTrialsLead PhaseDrugs
Neurocrine Biosciences, Inc.NBIX5PHASE3NBI-1117568
Bristol-Myers Squibb CompanyBMY8PHASE3KarXT
LB Pharmaceuticals, Inc.LBRX2PHASE3LB-102
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Vanda Pharmaceuticals Inc.VNDA1PHASE3iloperidone
Eli Lilly and CompanyLLY2PHASE2Brenipatide
Novartis AG Sponsored ADRNVS1PHASE2GXV813
Reviva Pharmaceuticals Holdings, Inc.RVPH1PHASE3Brilaroxazine
AbbVie, Inc.ABBV1PHASE2Emraclidine
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-101
Anavex Life Sciences Corp.AVXL1PHASE2ANAVEX3-71
Minerva Neurosciences IncNERV1PHASE3Roluperidone, risperidone, aripiprazole, olanzapine
MapLight Therapeutics, Inc.MPLT1PHASE2ML-007C-MA
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
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Frequently asked questions about AZD8529

What is AZD8529 used for?

AZD8529 is an investigational small molecule being studied for schizophrenia and related cognitive and memory impairments. Clinical development has focused on adult schizophrenia patients, including effects on cognition and negative symptoms, as well as healthy volunteers. It is not approved and remains in clinical development.

Who makes AZD8529?

AZD8529 is being developed by AstraZeneca PLC, traded on the NASDAQ under the ticker AZN. The company has sponsored clinical trials of the drug in the United States and the United Kingdom.

What phase is AZD8529 in?

AZD8529 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in schizophrenia patients, which has been completed. The drug is investigational and not approved for any use.

What clinical trials is AZD8529 in?

AZD8529 has been studied in several completed trials, including NCT00886756, a single ascending dose study in healthy Japanese subjects; NCT00921804, a Phase 2 efficacy and safety study in schizophrenia patients; NCT00985933, a study on ketamine-induced working memory impairment in healthy volunteers; and NCT00986531, a study on cognition and negative symptoms in schizophrenia.

Is AZD8529 the same as any other drug?

AZD8529 is the sole name used for this investigational compound in the clinical trial data. No alternative names have been identified in the available information.