Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Capivasertib film-coated · 1 trial · 1 indication
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...
Capivasertib film-coated is a small molecule drug developed by AstraZeneca PLC (ticker: AZN). It is an investigational agent that has been studied in a Phase 1 clinical trial. The film-coated formulation refers to the oral tablet form, specifically the 200 mg strength, which is also known as Capivasertib film-coated tablet, 200 mg.
Capivasertib film-coated targets AKT1, AKT2, and AKT3. It is an inhibitor of these AKT isoforms, which are serine/threonine kinases involved in cell signaling pathways. By inhibiting AKT, the drug aims to interfere with processes that promote cell growth and survival.
Capivasertib film-coated is being developed by AstraZeneca PLC, a pharmaceutical company traded under the ticker AZN. AstraZeneca is responsible for the clinical development of this investigational drug.
Capivasertib film-coated is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently approved by the FDA. The drug remains investigational and further studies are needed to establish its safety and efficacy.
Capivasertib film-coated has been studied in one completed Phase 1 trial, NCT05419401. This trial investigated the absolute bioavailability, absorption, metabolism, distribution, and excretion of [14C]AZD5363 (Capivasertib) in healthy male volunteers in the United Kingdom. The trial enrolled 7 participants and is now completed.