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 a nano-suspension formulation of AZD4635, a small molecule developed by AstraZeneca PLC. It was studied as a 50 mg nano-suspension reference formulation in a Phase 1 relative bioavailability trial in healthy male volunteers in the United Kingdom. The program is listed as Phase 1 and the trial has been completed.
AZD4635 nano is made by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the developer of the AZD4635 nano-suspension formulation and sponsored the Phase 1 relative bioavailability study conducted in the United Kingdom.
AZD4635 nano is in Phase 1 development. One Phase 1 trial has been completed and no trials are currently active. The completed study was a relative bioavailability study of the AZD4635 50 mg nano-suspension reference formulation in healthy volunteers.
AZD4635 nano has been studied in one clinical trial, NCT03710434, titled AZD4635 Relative Bioavailability Study. It was a completed Phase 1 controlled trial that enrolled 21 healthy male volunteers aged 18 years and older in the United Kingdom. The study was randomized but not double blind.