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The purpose of the study is to assess the effect of AZD0780 on the pharmacokinetics of rosuvastatin, and to assess the safety and tolerability of AZD0780 single dose, in healthy participants administered alone and in combination with rosuvastatin.
Eligible participants will be randomized, in a 1:1 ratio into 2 of the treatment arms. Each participant will receive 2 treatments in total throughout the study. The following treatments will be given in randomized order in fasting state:
Treatment A: single dose of rosuvastatin tablet alone
Treatment B: single dose of rosuvastatin tablet + AZD0780 tablet
The study will comprise:
Following an overnight fast (minimum 10 hours) participants will receive either of the two treatments and will remain resident in the Clinical Unit until up to 48 hours after dosing of the study drug (up to Day 3).
The total duration of the study will be up to 9 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence A-B | Experimental | Participants will receive treatments in the following sequence, a single dose of rosuvastatin tablet alone (Treatment A) in period 1, and then a single dose of rosuvastatin tablet + Dose X AZD0780 tablet (Treatment B) in period 2. |
|
| Treatment sequence B-A | Experimental | Participants will receive 1 treatment during each study period in the following sequence: a single dose of rosuvastatin tablet + AZD0780 tablet (Treatment B) in period 1 and then a single dose of rosuvastatin tablet alone (Treatment A) in period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0780 | Drug | AZD0780 will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under plasma concentration-time curve from 0 to infinity (AUCinf) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Maximum observed plasma concentration (Cmax) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Terminal elimination half-life (t½λz) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Time to reach maximum observed concentration (tmax) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Apparent total body clearance (CL/F) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | The safety and tolerability of AZD0780 in combination with rosuvastatin in healthy participants will be assessed. | From Screening (≤ 28 days to Day -2) until Follow-up Visit (10 to 12 days post-final dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brooklyn | Maryland | 21225 | United States |
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| Label | URL |
|---|---|
| CSR Synopsis D7960C00002 | View source |
| Results of this clinical trial are available on www.astrazenecaclinicaltrials.com | 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.
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 rerefer 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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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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Participants will be randomized, in a 1:1 ratio into each of the treatment arms prior to the study commencing. Each participant will receive 2 treatments in total throughout the study.
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| Rosuvastatin | Drug | Rosuvastatin will be administered orally as a single dose after an overnight fast of at least 10 hours with approximately 240 mL of water. |
|
| Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Rosuvastatin | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Area under plasma concentration-time curve from 0 to infinity (AUCinf) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Area under the plasma concentration-curve from 0 to the last quantifiable concentration (AUClast) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Maximum observed plasma concentration (Cmax) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Time to reach maximum observed concentration (tmax) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Terminal elimination half-life (t½λz) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Apparent total body clearance (CL/F) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of AZD0780 | The effect of AZD0780 on the PK of rosuvastatin in healthy participants will be assessed. | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post-dose |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |