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AZ14132516

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Jul 14, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

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
Healthy Volunteers
NCT058185148
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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 (AZN). It is currently in Phase 1 clinical development, studied in healthy volunteers. A completed early Phase 1 trial evaluated its biodistribution and binding characteristics using a radiolabeled form, [11C]AZ14132516, in eight healthy participants in Sweden.

What does AZ14132516 target?

The molecular target of AZ14132516 is not disclosed in the available information. The completed clinical trial focused on determining the biodistribution and binding characteristics of the radiolabeled compound [11C]AZ14132516 in healthy participants, which is typical for early-phase imaging studies.

Who makes AZ14132516?

AZ14132516 is developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this investigational small molecule in healthy volunteers.

What phase is AZ14132516 in?

AZ14132516 is in Phase 1 clinical development. The single clinical trial for this drug, NCT05818514, was an early Phase 1 study that has been completed. The drug is investigational and has not been approved for any medical use.

What clinical trials is AZ14132516 in?

AZ14132516 has one clinical trial, NCT05818514, titled "A PET Study to Determine Biodistribution and Binding Characteristics of [11C]AZ14132516 in Healthy Participants." This early Phase 1 study was completed, enrolled eight healthy volunteers, and was conducted in Sweden. It was an uncontrolled, non-randomized, open-label study.

Is AZ14132516 the same as [11C]AZ14132516?

AZ14132516 and [11C]AZ14132516 are related compounds. The clinical trial NCT05818514 used [11C]AZ14132516, which is the carbon-11 radiolabeled version of AZ14132516, designed for positron emission tomography (PET) imaging to study the biodistribution and binding of the drug in the body.