Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD5462 film-coated tablet
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...
Top 16 of 30 competitors
AZD5462 film-coated is an investigational small molecule being studied for heart failure. It has been evaluated in a Phase 1 clinical trial in healthy male volunteers, not in patients with heart failure. AstraZeneca PLC is developing the drug, and it has not been approved for any indication.
AZD5462 film-coated is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this small molecule heart failure candidate.
AZD5462 film-coated is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for heart failure or any other indication.
AZD5462 film-coated has been studied in one completed Phase 1 trial, NCT06989983. The trial assessed mass balance recovery, absorption, metabolism, excretion of [14C]AZD5462, and the absolute bioavailability of AZD5462. It enrolled 8 healthy male volunteers in the United Kingdom and was uncontrolled, with no randomization or blinding.
Yes, AZD5462 film-coated and AZD5462 film-coated tablet refer to the same investigational drug candidate from AstraZeneca PLC. The film-coated tablet is the oral dosage form used in the Phase 1 study of this small molecule for heart failure.