Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5462 film-coated · 1 trial · 1 indication
Mass balance recovery of total radioactivity of \[14C\]AZD5462 in urine and faecal samples
Mass balance recovery of total radioactivity of \[14C\]AZD5462 in urine and faecal samples
Mass balance recovery of total radioactivity of \[14C\]AZD5462 in urine and faecal samples
Mass balance recovery of total radioactivity of \[14C\]AZD5462 in urine and faecal samples
Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose
| Arm | Type | Description |
|---|---|---|
| AZD5462 | EXPERIMENTAL | In Period 1, participants will receive one oral dose of \[14C\]AZD5462. In Period 2, participants will receive one oral dose of AZD5462 and one intravenous dose of \[14C\]AZD5462. |
| Name | Type | Description |
|---|---|---|
| AZD5462 film-coated tablet | DRUG | Oral, fasted |
| [14C]AZD5462 Solution for Infusion | DRUG | Intravenous, fasted |
| [14C]AZD5462 Oral Solution | DRUG | Oral, fasted |
Inclusion Criteria: * Healthy males aged 30 to 65 years inclusive * BMI in the range 18.0 - 32.0 kg/m2 inclusive and body weight ≥ 50 kg and ≤ 100 kg * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * History of any clinically significant d...
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AZD5462 is an investigational small molecule being developed for heart failure. It is a film-coated oral formulation currently in Phase 1 clinical development. The drug is being studied to assess its absorption, metabolism, and excretion in the body, specifically in the context of heart failure treatment.
AZD5462 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's pharmacokinetic properties in patients with heart failure.
AZD5462 is in Phase 1 clinical development. A Phase 1 study has been completed, which enrolled 8 participants to evaluate the drug's mass balance recovery, absorption, metabolism, excretion, and absolute bioavailability. The drug is investigational and has not been approved by regulatory authorities.
AZD5462 has one completed clinical trial registered under NCT06989983. This Phase 1 study assessed the mass balance recovery, absorption, metabolism, and excretion of [14C]AZD5462, as well as the absolute bioavailability of AZD5462. The trial was conducted in the United Kingdom with 8 male participants.
AZD5462 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on pharmacokinetic properties rather than efficacy or safety for regulatory approval. Further clinical studies would be required before any approval decision.