Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 14C]AZD4831 Oral Solution
14C AZD4831 · 1 trial · 1 indication
Assessment of the total radioactivity by measuring the cumulative amount of AZD4831 excreted (CumAe)
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 and structural identification by AMS analysis
Assessment of metabolites and structural identification by AMS analysis
Assessment of metabolites and structural identification by AMS analysis
| Arm | Type | Description |
|---|---|---|
| [14C]AZD4831 Oral Solution | EXPERIMENTAL | One 10 mg dose of \[14C\]AZD4831 Oral Solution |
| Name | Type | Description |
|---|---|---|
| 14C]AZD4831 Oral Solution | DRUG | 10 mg dose of \[14C\]AZD4831 Oral Solution |
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)...
Top 4 of 19 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Roivant Sciences Ltd. | ROIV | 3 | PHASE3 | Mosliciguat |
| Eli Lilly and Company | LLY | 1 | PHASE3 | Lepodisiran |
| Illumina, Inc. | ILMN | 1 | PHASE1 | 18F-mFBG for administration |
14C AZD4831 is a carbon-14 radiolabeled oral solution formulation of AZD4831, a small molecule being developed by AstraZeneca PLC. It is used in clinical pharmacology research rather than as a therapeutic product itself. The radiolabel allows researchers to track how the drug is absorbed, distributed, metabolized, and excreted in the human body.
14C AZD4831 is used in a Phase 1 mass balance study to characterize the pharmacokinetics, metabolite profile, and metabolite identification of AZD4831 in healthy male volunteers. The study is conducted in the cardiovascular disease therapeutic area. It is a research tool for understanding how the body processes AZD4831, not a treatment administered for therapeutic benefit.
AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN, is the developer of 14C AZD4831. The company sponsors the clinical pharmacology study evaluating this radiolabeled oral solution formulation. AstraZeneca is a global biopharmaceutical company headquartered in the United Kingdom.
14C AZD4831 is in Phase 1 development. The single clinical trial of this radiolabeled formulation has been completed. It is an investigational agent and is not approved by the FDA. The Phase 1 study was conducted in the United Kingdom and enrolled 8 healthy male volunteers.
14C AZD4831 has been studied in one completed Phase 1 trial, NCT04407091, titled A Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolite Profile and Metabolite Identification of [14C]AZD4831. The trial enrolled 8 healthy male volunteers aged 18 years and older in the United Kingdom. It was an uncontrolled study without randomization or blinding.
Yes, 14C AZD4831 and [14C]AZD4831 Oral Solution refer to the same investigational product. The bracketed carbon-14 notation and the oral solution description identify the radiolabeled formulation used in the Phase 1 mass balance study. Both names describe the same AstraZeneca compound evaluated in trial NCT04407091.