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AZ14132516

Phase 1

Crohn's Disease | Small molecule | Other |AstraZeneca PLC|Trials Updated: Jul 14, 2023

AZ14132516 target and mechanism

ModalitySmall molecule

Also known as [11C]AZ14132516

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

AZ14132516 clinical trials

AZ14132516 · 1 trial · 1 indication

Early Phase 1 1
NCT05818514A PET Study to Determine Biodistribution and Binding Characteristics of [11C]AZ14132516 in Healthy ParticipantsHealthy Volunteers
COMPLETED8 Analytics
EARLY_PHASE1COMPLETED
A PET Study to Determine Biodistribution and Binding Characteristics of [11C]AZ14132516 in Healthy Participants
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Study Endpoints

Primary Endpoints

SUV and SUVR in abdominal regions of interest
Immediately following administration of radioligand

Standardized uptake value (SUV) is the radioactivity concentration in given region of interest normalized for injected radioactivity and body weight. Standardised uptake value ratio (SUVR) is the ratio of SUV in a given region of interest to a reference region without significant radioligand uptake

Secondary Endpoints

Absolute percentage differences of SUV and SUVR, and intraclass correlation coefficients, in regions of interest between two test-retest PET examinations
10-14 days following initial administration of radioligand
Number of participants with safety findings, AEs
Through study completion, up to 49 days (including screening period)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
[11C]AZ14132516EXPERIMENTALPilot panel: up to 3 participants to complete 1 PET examination each during the course of the study Main panel: up to 6 participants to complete 2 PET examinations each during the course of the study

Interventions

NameTypeDescription
[11C]AZ14132516DRUGInjection of radioligand for PET examinations
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Eligibility Criteria

SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Informed Consent 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. 2. Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete a...

Countries:Sweden
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Frequently asked questions about AZ14132516

What is AZ14132516?

AZ14132516 is an investigational small molecule being developed by AstraZeneca PLC under the ticker AZN. It is being studied in Crohn's disease and is currently in Phase 1 clinical development. The compound has also been evaluated as a positron emission tomography tracer in healthy volunteers.

What is AZ14132516 used for in Crohn's disease?

AZ14132516 is being developed as a potential treatment for Crohn's disease, an inflammatory condition of the gastrointestinal tract. It remains investigational and is in Phase 1 development, so it is not approved for any indication. No efficacy results in Crohn's disease have been reported.

Who makes AZ14132516?

AZ14132516 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating the compound, including the early-phase PET imaging study conducted in Sweden.

What phase is AZ14132516 in?

AZ14132516 is in Phase 1 clinical development. One trial has been completed, an early Phase 1 PET study, and no trials are currently active. The compound is investigational and has not been approved by the FDA or any other regulatory agency for Crohn's disease or any other indication.

What clinical trials is AZ14132516 in?

AZ14132516 has been evaluated in one completed clinical trial, NCT05818514, titled a PET study to determine biodistribution and binding characteristics of [11C]AZ14132516 in healthy participants. The trial enrolled 8 healthy volunteers in Sweden and was an early Phase 1, uncontrolled study.

Is AZ14132516 the same as [11C]AZ14132516?

Yes, [11C]AZ14132516 is an alternative name for AZ14132516. The bracketed form refers to the carbon-11 radiolabeled version of the compound used as a positron emission tomography tracer in the completed Phase 1 imaging study NCT05818514.