Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD5004 film-coated · 1 trial · 1 indication
Absolute bioavailability (F) based on AUC0-inf of oral and IV administration, adjusted for dose
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
Mass balance recovery of total radioactivity (TR) in urine, faeces and all excreta (urine and faeces combined)
| Arm | Type | Description |
|---|---|---|
| AZD5004 | EXPERIMENTAL | A single dose of AZD5004 film-coated tablet and a single dose of \[14C\]AZD5004 Solution for Infusion (Part 1) A single dose of \[14C\]AZD5004 Oral Solution (Part 2) |
| Name | Type | Description |
|---|---|---|
| AZD5004 film-coated tablet | DRUG | oral, fasted |
| [14C]AZD5004 Solution for Infusion | DRUG | intravenous, fasted |
| [14C]AZD5004 Oral Solution | DRUG | oral, fasted |
Inclusion Criteria: * Healthy males aged 30 to 65 years inclusive * BMI in the range 18.0 - 35.0 kg/m2 and body weight ≥63 kg * Regular bowel movements (i.e. average stool production of ≥1 and ≤3 stools per day) Exclusion Criteria: * History of any clinically significant disease or disorder * His...
AZD5004 film-coated is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a completed trial assessing its mass balance, absorption, distribution, metabolism, and excretion, as well as its absolute bioavailability.
AZD5004 film-coated is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical research on this investigational small molecule in healthy participants.
AZD5004 film-coated is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials.
AZD5004 film-coated has one completed Phase 1 trial, NCT06857695, titled "A Study to Assess the Mass Balance and ADME of [14C]AZD5004 and the Absolute Bioavailability of AZD5004." This trial enrolled 8 healthy male participants in the United Kingdom.
AZD5004 film-coated is a formulation of the drug AZD5004. The clinical trial NCT06857695 specifically studies the film-coated tablet form, and the drug is referred to as AZD5004 throughout the trial documentation.