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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05419401 | A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of [14C]AZD5363 (Capivasertib) | PHASE1 | COMPLETED | 7 | — | — | Apr 11, 2022 | Jul 12, 2022 | Jul 22, 2022 | 1 | United Kingdom |
Absolute bioavailability (F) of oral capivasertib compared to \[14C\]-capivasertib (part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)
PK of capivasertib and \[14C\]AZD5363 (capivasertib) in plasma (Part 1)
PK (plasma and urine) and total radioactivity (whole blood and plasma) of capivasertib (Part 2)
Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)
Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)
Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)
Mass balance recovery of \[14C\]AZD5365 (capivasertib) from urine and faecal samples (Part 2)
Blood:plasma concentration ratios of total radioactivity (Part 2)
| Arm | Type | Description |
|---|---|---|
| Capivasertib | EXPERIMENTAL | film-coated tablet, 200 mg |
| [14C]AZD5363 (Capivasertib) | EXPERIMENTAL | Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) and Oral Solution, 400 mg (NMT 4.8 MBq) |
| Name | Type | Description |
|---|---|---|
| Capivasertib film-coated tablet, 200 mg | DRUG | 400mg dose, oral, fasted |
| [14C]AZD5363 (Capivasertib) | DRUG | Solution for Infusion 20 µg/mL (NMT 37.0 kBq/5 mL) - 100 µg; 5 mL, Intravenous Oral Solution, 400 mg (NMT 4.8 MBq) - 400mg; 100mL, oral, fasted |
Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures. * Must be willing and able to communicate and participate in the whole study. * Healthy males aged 30 to 65 years inclusive at the time of signing informed consent. * Must be vasect...