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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food (fed state) or without food (fasted state).
This will be an Open-Label, Five-Period Study in healthy subjects. The study will comprise of a Screening Period of maximum 28 days.
The treatment groups are as follows:
Five (5) periods during which subjects will participate from Day -1 of Period 1 to 72 hours after the AZD5055 dose in Period 5.
A Follow-up Visit, or telephone call, approximately 6 days after the last AZD5055 dose in Period 5.
There will be a minimum washout of 3 days between the AZD5055 dose administration in Period 1 and Period 2 and a minimum washout of 4 days between AZD5055 doses administrations for subsequent study periods.
Each subject will participate in the study for approximately 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Subjects will receive AZD5055 solution as a 20-minute infusion in overnight fasted state on Day 1 in Period 1. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration time curve from time 0 to infinity (AUCinf) |
| Day 1-6, 8-10, 13-15, 17-19 |
| Area under the concentration time curve from time 0 to the last quantifiable concentration (AUClast) |
| Day 1-6, 8-10, 13-15, 17-19 |
| Maximum observed concentration (Cmax) |
| Day 1-6, 8-10, 13-15, 17-19 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, MD | PAREXEL Early Phase Clinical Unit Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brooklyn | Maryland | 21225 | United States |
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| Label | URL |
|---|---|
| D8960C00002\_CSR Synopsis\_Redacted.pdf | View source |
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Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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| 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. |
|
| 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. |
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| AZD5055 film-coated tablet | Drug | Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in fed state (either a high fat meal or low-fat meal calorie standard breakfast) |
|
| 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]. |
|
| Rabeprazole, Delayed-release tablet | Drug | Subjects will receive oral doses of rabeprazole twice daily prior to AZD5055 single dose under fed conditions (low-fat standard breakfast) and then continued for 2 days. |
|
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D013608 | Tablets, Enteric-Coated |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013607 | Tablets |
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