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The purpose of this study is to evaluate the pharmacokinetics (PK) of rosuvastatin when administered alone and in combination with single oral dose of AZD4144.
This is a Phase 1, randomized, open label study in healthy participants.
The participants will be provided with:
Treatment A: single dose of rosuvastatin Treatment B: single dose of rosuvastatin in combination with AZD4144. The participants will be randomized in the 1:1 ratio to either receive treatment sequence AB or sequence BA.
The study will be comprised of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence AB | Experimental | Participants will receive single dose of rosuvastatin under fasted condition (Treatment A), followed by a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B). |
|
| Treatment sequence BA | Experimental | Participants will receive a single dose of rosuvastatin with AZD4144 under fasted condition (Treatment B), followed by a single dose of rosuvastatin under fasted condition (Treatment A). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4144 | Drug | Oral tablet of AZD4144 will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration-time curve from 0 to infinity (AUCinf) | The AUCinf of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated. | Day 1 to Day 4 and Day 10 to Day 13 |
| Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) | The AUClast of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated. | Day 1 to Day 4 and Day 10 to Day 13 |
| Maximum plasma drug concentration (Cmax) | The Cmax of rosuvastatin when administered alone and in combination with AZD4144 in healthy participants will be evaluated. | Day 1 to Day 4 and Day 10 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | The safety and the tolerability of AZD4144 in combination with rosuvastatin will be evaluated. | From screening (Day-28 to Day -2) until Follow-up (Day 20) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | HA1 3UJ | United Kingdom |
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 anonymized individual patient-level data via secure researchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Rosuvastatin | Drug | Oral tablet of rosuvastatin will be administered. |
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |