Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06989983 | A Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism, Excretion of [14C]AZD5462 and the Absolute Bioavailability of AZD5462 | PHASE1 | COMPLETED | 8 | — | — | May 20, 2025 | Jun 25, 2025 | Jul 4, 2025 | 1 | United Kingdom |
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...