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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05630677 | A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects. | PHASE1 | COMPLETED | 21 | — | — | Nov 4, 2022 | Feb 9, 2023 | Mar 4, 2024 | 1 | United States |
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered.
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Subjects will receive AZD5055 solution as a 20-minute infusion in overnight fasted state on Day 1 in Period 1. |
| Treatment B | EXPERIMENTAL | Subjects will receive oral suspension of AZD5055 in an overnight fasted state on Day 1 in Period 1. |
| Treatment C | EXPERIMENTAL | Subjects will receive AZD5055 film-coated tablet in overnight fasted state on Day 1 (Study Day 4) in Period 2. |
| Treatment D | EXPERIMENTAL | Subjects will receive a standardized high-fat breakfast 30 minutes before film-coated tablet of AZD5055 administered as On Day 1 (Study Day 8) in Period 3. |
| Treatment E | EXPERIMENTAL | Subjects will receive rabeprazole twice daily on Day 10. On Day 1 (Study Day 13), AZD5055 film-coated tablet will be administered, under fasted conditions, together with rabeprazole and rabeprazole dosing will continue twice daily in Period 4. |
| Treatment F | EXPERIMENTAL | Subjects will receive a low-fat breakfast 30 minutes before AZD5055 film-coated tablet administered together with rabeprazole on Day 17. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18 in Period 5. |
| Name | Type | Description |
|---|---|---|
| AZD5055 solution for infusion | DRUG | Subjects will receive a single dose intravenous infusion of AZD5055 as 20-minute infusion on Day 1 of the respective period in overnight fasted state. |
| AZD5055 oral suspension | DRUG | Subjects will receive single dose of AZD5055 oral suspension on Day 1 of the respective period in overnight fasted state. |
| AZD5055 film-coated tablet | DRUG | Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in overnight fasted state. |
| Rabeprazole, Delayed-release tablet | DRUG | Subjects will receive oral doses of rabeprazole twice daily 3 days prior to AZD5055 single dose and 4 days after the AZD5055 single dose including the day that AZD5055 is dosed under fasted conditions \[Study Day 10 to 18\]. |
Inclusion Criteria: 1. Healthy male and female (of non-childbearing potential) subjects aged 18 to 55 years. 2. Female subjects must have a negative pregnancy test. 3. Male subjects must adhere to the contraception methods as per Protocol. 4. Have a BMI between 18 and 30 kg/m2 inclusive. Exclusion...