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AZD0328

Phase 1

Alzheimer's Disease | Small molecule | Neurology |AstraZeneca PLC|Last Updated: Dec 10, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

AZD0328 · 3 trials · 3 indications

Phase 1 3
NCT00752830To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328Healthy
COMPLETED14 Analytics
NCT00738959Safety, Tolerability & PK of AZD0328 in Caucasian & JapaneseHealthy Volunteers
COMPLETED64 Analytics
NCT00687141Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy SubjectsAlzheimer's Disease
COMPLETED112 Analytics
PHASE1COMPLETED
To Evaluate the Effect of Food on the Pharmacokinetics (PK) of AZD0328
HealthyUnlock trial analytics
PHASE1COMPLETED
Safety, Tolerability & PK of AZD0328 in Caucasian & Japanese
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD0328 in Elderly Healthy Subjects
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

PK variables
Several PK samples during the study days
Safety variables (adverse events, vital signs, paper ECGs and 12-lead continuous digital ECGs including QT/QTc interval measurements
During the whole treatment period
Safety and tolerability of AZD0328 by assessment of vital signs, laboratory variables and ECG
Assessments taken at visit 1 (enrolment), during visit 2 (residential period) and follow up visit 3.
Safety and tolerability of AZD0328 by assessment of adverse events
Non serious adverse events will be collected from the start of residential period until the end of the study. Serious adverse events will be collected from signing of consent until end of study.

Secondary Endpoints

Safety variables (adverse events, blood pressure, laboratory measurements and paper ECGs)
During the whole treatment period
PK variables
Several samples during the study days
Determine the single and multiple dose pharmacokinetics (PK) of AZD0328
PK sampling taken at defined timepoints during residential period.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALAZD0328 administration during fasting condition
2EXPERIMENTALAZD0328 administration after food intake

Interventions

NameTypeDescription
AZD0328DRUGOral capsule, single dose
PlaceboDRUGAdministered orally as a solution once per day on day 1, and then day 3 through to day 14.
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male Caucasian subjects. * Clinically normal physical findings, laboratory values, vital signs and resting ECG as judged by the investigator. * Signed informed consent form Exclusion Criteria: * History of clinically significant cardio or cerebrovascular, pulmonary, ...

Countries:SwedenUnited Kingdom
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Frequently asked questions about AZD0328

What is AZD0328 used for?

AZD0328 is an investigational small molecule being studied for use in Alzheimer's disease and in healthy volunteers. It has been evaluated in Phase 1 clinical trials to assess its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is being developed by AstraZeneca PLC and is not yet approved.

Who makes AZD0328?

AZD0328 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company has sponsored Phase 1 clinical trials of this investigational small molecule in healthy volunteers and in subjects with Alzheimer's disease.

What phase is AZD0328 in?

AZD0328 is in Phase 1 clinical development. It has completed three Phase 1 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities. Its development status reflects early-stage testing in humans.

What clinical trials is AZD0328 in?

AZD0328 has completed three Phase 1 clinical trials: NCT00687141, which studied safety and tolerability in elderly healthy subjects in Sweden; NCT00738959, which assessed safety and pharmacokinetics in Caucasian and Japanese male subjects in the United Kingdom; and NCT00752830, which evaluated the effect of food on pharmacokinetics in Sweden.

Is AZD0328 FDA approved?

AZD0328 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials, which are early-stage studies focused on safety and tolerability. The drug remains in clinical development and has not received marketing approval for any indication.