Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD4635 nano · 1 trial · 1 indication
Assessment of maximum concentration (Cmax) in plasma
Assessment of exposure through measurement of area under the curve (AUC) in plasma
| Arm | Type | Description |
|---|---|---|
| Part A - nano-suspension | EXPERIMENTAL | Subjects will receive single dose of AZD4635 50mg nano-suspension (reference) in the fasted state. |
| Part A - solid oral formulation | EXPERIMENTAL | Subjects will receive single dose of AZD4635 50mg solid oral formulation, in the fasted state. |
| Part B-solid oral formulation with food | EXPERIMENTAL | Subjects will receive a single dose AZD4635 solid oral formulation after high fat meal. |
| Part B - solid oral formulation with PPI | EXPERIMENTAL | Subjects will receive 30 mg lansoprazole BID and a single dose of AZD4635 solid oral formulation in the fasted state. |
| Part B - dose exploration 1 | EXPERIMENTAL | If dose adjustment is required, subjects will receive a different single dose (XX mg) of AZD4635 solid oral formulation, in the fasted state. |
| Part B - dose exploration 2 | EXPERIMENTAL | If dose adjustment is required, subjects will receive a different single dose (YY mg) of AZD4635 solid oral formulation, in the fasted state. |
| Part B - variant 1 | EXPERIMENTAL | Subjects will receive a single dose of AZD4635 solid oral formulation, variant 1 in the fasted state and optional \[14C\] AZD4635 IV microtracer. |
| Part B - variant 2 | EXPERIMENTAL | Subjects will receive a single dose of AZD4635 solid oral formulation, variant 2 in the fasted state. |
| Name | Type | Description |
|---|---|---|
| AZD4635 50 mg nano-suspension (reference) | DRUG | Subjects will receive a single dose of AZD4635 50 mg nano-suspension (reference) in the fasted state. |
| AZD4635 solid oral formulation - fasted | DRUG | Subjects will receive a single dose of AZD4635 solid oral formulation, in the fasted state. |
| AZD4635 solid oral formulation - fed | DRUG | Subjects will receive a single dose of AZD4635 solid oral formulation, in the fed state. |
| Lansoprazole and AZD4635 50 mg solid oral formulation | DRUG | Subjects will receive lansoprazole 30 mg BID for 5 days followed by a single dose of AZD4635 50 mg solid oral formulation in the fasted state. |
| AZD4635 solid oral formulation variant 1 - fasted | DRUG | Subjects will receive a single dose of AZD4635 solid oral formulation, variant 1 in the fasted state. |
| AZD4635 solid oral formulation variant 2 - fasted | DRUG | Subjects will receive a single dose of AZD4635 solid oral formulation, variant 2 in the fasted state. |
| [14C] AZD4635 IV microtracer - fasted | DRUG | Subjects will receive a single dose of \[14C\] AZD4635 IV microtracer. This intervention will be co-administered with AZD4635 solid oral formulation variant 1. |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male subjects aged 18 to 55 years with suitable veins for cannulation or repeated venepuncture and IV infusion. 3. Have a body mass index of 18.0 to 32.0 kg/m2, and weig...
AZD4635 nano is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its relative bioavailability. The drug is not approved and remains under investigation for potential future therapeutic use.
AZD4635 nano is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.
AZD4635 nano is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers, and it has not been approved by regulatory authorities. The drug remains in early-stage clinical testing as part of AstraZeneca's research pipeline.
AZD4635 nano has one completed clinical trial, identified as NCT03710434, titled 'AZD4635 Relative Bioavailability Study.' This Phase 1 study enrolled 21 healthy male volunteers in the United Kingdom, aged 18 years and older, and was a controlled, randomized trial.
AZD4635 nano is a formulation of the investigational drug AZD4635, studied in a Phase 1 relative bioavailability trial. The 'nano' designation refers to a nanoparticle formulation, which was evaluated in healthy volunteers to compare its absorption with other formulations.