Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD5055 solution for infusion
AZD5055 for infusion · 1 trial · 1 indication
* 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...
AZD5055 for infusion is an investigational small molecule developed by AstraZeneca PLC. It is also known as AZD5055 solution for infusion. The clinical program to date has studied AZD5055 in healthy adult volunteers rather than in a specific patient population, and no therapeutic indication has been disclosed for the asset.
AZD5055 for infusion is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical work conducted on the compound, including the Phase 1 study listed for AZD5055 in healthy subjects.
AZD5055 for infusion is in Phase 1 development. The program has one completed Phase 1 trial and no active trials. Because the compound is still in clinical development, it is investigational and has not been approved by the FDA for any use.
AZD5055 has been evaluated in one completed Phase 1 trial, NCT05630677, titled a study comparing the bioavailability of AZD5055 film-coated tablet with AZD5055 oral suspension and assessing the effect of food and an acid reducing agent on pharmacokinetics in healthy subjects. It enrolled 21 participants in the United States.
Yes. AZD5055 for infusion and AZD5055 solution for infusion refer to the same AstraZeneca compound, and AZD5055 is the underlying drug name used across the program. The solution for infusion wording describes the intravenous formulation of the same investigational small molecule.
The completed Phase 1 trial NCT05630677 was a controlled, randomized study that enrolled 21 healthy adult volunteers aged 18 years and older in the United States. It was not double blind, and it examined bioavailability along with the effects of food and an acid reducing agent on AZD5055 pharmacokinetics.