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AZD2624

Phase 2

Schizophrenia | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Mar 29, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment106

FDA Designations

No designations recorded

Clinical trial landscape

AZD2624 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT00686998Phase IIA Study in Patients With SchizophreniaSchizophrenia
COMPLETED106 Analytics
PHASE2COMPLETED
Phase IIA Study in Patients With Schizophrenia
Schizophrenia
NCT00686998106
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Study Endpoints

Primary Endpoints

Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline
Baseline, Day 28

PANSS total score, sum of 30 item scores (each on a 0 to 7 scale), assesses positive and negative symptoms of psychopathology on a continuous scale from 0 (the best) to 210 (the worst). Day 28 value was calculated using last observation carried forward (LOCF). Change from baseline was calculated as Day 28 value minus baseline value.

Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state.
Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study.
To assess the safety and tolerability of multiple ascending oral doses of AZD2624 in young healthy male Japanese subjects compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, ECGs and EEGs
All assessments are made at each visit, at least daily, during the study.

Secondary Endpoints

Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs.
Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period
To evaluate and characterize the pharmacokinetics of AZD2624 and its metabolites when given orally in multiple ascending doses of AZD2624 to young healthy male Japanese subjects by assessment of drug concentration in plasma
Blood samples will be taken before and after study drug administration.
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD2624
A single blood sample will be obtained
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD2624EXPERIMENTALAZD2624 40 mg
OlanzapineOTHEROlanzapine 15 mg
PlaceboPLACEBO_COMPARATORMatching Placebo
Treatment AEXPERIMENTALSingle oral dose of 40 mg AZD2624 liquid suspension in a fasted state.
Treatment BEXPERIMENTALSingle oral dose of 40 mg (2x20mg tablets)AZD2624 in a fasted state.
Treatment CEXPERIMENTALSingle oral dose of 40 mg (2x20mg tablets) in a fed state.
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
AZD2624DRUGOral Suspension
OlanzapineDRUGPO BID
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Females of non-childbearing potential * Diagnosis of Schizophrenia Exclusion Criteria: * Clinically relevant disease and /or abnormalities. * Alcohol or substance abuse not in remission * Enrollment in another investigational study within 30 days

Countries:United StatesJapan
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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 AZD2624

What is AZD2624 used for?

AZD2624 is an investigational small molecule being studied for schizophrenia and as a safety and tolerability assessment in healthy volunteers. It has been evaluated in clinical trials in the United States and Japan. The drug is not approved and remains in clinical development.

Who makes AZD2624?

AZD2624 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company has sponsored clinical trials of the drug in patients with schizophrenia and in healthy volunteers in the United States and Japan.

What phase is AZD2624 in?

AZD2624 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and is not FDA approved. The most advanced completed study was a Phase 2a trial in patients with schizophrenia.

What clinical trials is AZD2624 in?

AZD2624 has been studied in three completed trials: NCT00686998, a Phase 2a study in schizophrenia patients in the United States; NCT00696865, a Phase 1 multiple ascending dose study in healthy Japanese males; and NCT00867685, a Phase 1 bioavailability and food effect study in healthy volunteers.

Is AZD2624 the same as any other drug?

No alternative names for AZD2624 have been disclosed. The drug is identified solely by its code name AZD2624 in clinical trial registries and by its developer, AstraZeneca.