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14C AZD4831

Phase 1

Cardiovascular Disease | Small molecule | Cardiovascular |AstraZeneca PLC|Last Updated: Aug 25, 2020

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

14C AZD4831 · 1 trial · 1 indication

Phase 1 1
NCT04407091A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831Cardiovascular Disease
COMPLETED8 Analytics
PHASE1COMPLETED
A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831
Cardiovascular DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The cumulative amount of AZD4831 excreted (CumAe)
Urine and faecal samples collected from pre-dose until 336 hours post-dose

Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted (CumAe)

The cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)
Urine and faecal samples collected from pre-dose until 336 hours post-dose

Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted and expressed as a percentage of the administered dose (CumFe)

Assessment of metabolites in plasma by accelerator mass spectrometry (AMS) analysis
Collection of plasma samples from pre-dose until 336 hours post-dose

Assessment of metabolites and structural identification by AMS analysis

Assessment of metabolites in urine by AMS analysis
Collection of urine samples from pre-dose until 336 hours post-dose

Assessment of metabolites and structural identification by AMS analysis

Assessment of metabolites in faeces by AMS analysis
Collection of faecal samples from pre-dose until 336 hours post-dose

Assessment of metabolites and structural identification by AMS analysis

Secondary Endpoints

The amount of AZD4831 excreted (Ae)
Collection of urine and faecal samples from pre-dose to 336 hours post-dose.
Amount of AZD4831 excreted and expressed as a percentage of the administered dose (Fe)
Collection of urine and faecal samples from pre-dose to 336 hours post-dose
The cumulative amount of AZD4831 excreted (CumAe)
Collection of urine and faecal samples from pre-dose to 336 hours post-dose
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
[14C]AZD4831 Oral SolutionEXPERIMENTALOne 10 mg dose of \[14C\]AZD4831 Oral Solution

Interventions

NameTypeDescription
14C]AZD4831 Oral SolutionDRUG10 mg dose of \[14C\]AZD4831 Oral Solution
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 18 to 65 years inclusive at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture. 3. Body mass index (BMI)...

Countries:United Kingdom
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Frequently asked questions about 14C AZD4831

What is 14C AZD4831 used for?

14C AZD4831 is an investigational small molecule being studied for cardiovascular disease. It is a radiolabeled form of the drug, used in a Phase 1 clinical trial to assess mass balance recovery, pharmacokinetics, metabolite profile, and metabolite identification. The drug is still in clinical development and is not approved.

Who makes 14C AZD4831?

14C AZD4831 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this investigational drug for cardiovascular disease.

What phase is 14C AZD4831 in?

14C AZD4831 is in Phase 1 clinical development. The drug is investigational and has not been approved. One Phase 1 trial has been completed, and the drug is not currently in active trials.

What clinical trials is 14C AZD4831 in?

14C AZD4831 has one completed clinical trial, NCT04407091, titled "A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831." This Phase 1 study enrolled 8 male healthy volunteers in the United Kingdom.

Is 14C AZD4831 the same as AZD4831?

14C AZD4831 is a radiolabeled version of the drug AZD4831, where the carbon-14 isotope is incorporated for research purposes. This labeling allows researchers to track the drug's absorption, distribution, metabolism, and excretion in the body during clinical studies.