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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03710434 | AZD4635 Relative Bioavailability Study | PHASE1 | COMPLETED | 21 | — | — | Nov 1, 2018 | Apr 2, 2019 | May 7, 2020 | 1 | United Kingdom |
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...