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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The purpose of this study is to measure the effect of ticagrelor on the pharmacokinetics (PK) of rosuvastatin in healthy participants.
This study will be conducted at a single Clinical Unit. It includes 2 parallel arms (one for each rosuvastatin dose) and 2 treatment periods.
The study will comprise:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin (Dose 1) + Ticagrelor | Experimental | Participants will receive rosuvastatin (dose 1) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. During Period 2, participants will also receive ticagrelor 90 mg BID (twice a day) on Day 6 through Day 10. |
|
| Rosuvastatin (Dose 2) + Ticagrelor | Experimental | Participants will receive rosuvastatin (dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. During Period 2, participants will also receive ticagrelor 90 mg BID on Day 6 through Day 10. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | Participants will receive rosuvastatin (dose 1 or dose 2) orally as a single dose on Day 1 in Period 1 and Day 6 in Period 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under concentration-time curve from time 0 to infinity (AUCinf) | To assess the effect of ticagrelor on plasma PK (AUCinf) of rosuvastatin dose 1 and dose 2 separately, in healthy participants. | From Day 1 to Day 11 |
| Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) | To assess the effect of ticagrelor on plasma PK (AUClast) of rosuvastatin dose 1 and dose 2 separately, in healthy participants. | From Day 1 to Day 11 |
| Maximum observed drug concentration (Cmax) | To assess the effect of ticagrelor on plasma PK (Cmax) of rosuvastatin dose 1 and dose 2 separately, in healthy participants. | From Day 1 to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | To examine the safety and tolerability of rosuvastatin alone and in combination with ticagrelor. | Approximately 7 weeks |
| Terminal elimination half-life (t1/2) |
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Inclusion Criteria:
Healthy participants with suitable veins for cannulation or repeated venipuncture.
All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, to avoid pregnancy from the time of first administration of study intervention until 1 month after the study Follow-up Visit.
Females of non-childbearing potential must be confirmed at the Screening Visit by fulfilling one of the following criteria:
Sexually active fertile male participants with partners of childbearing potential must adhere to the specified contraception methods from the time of first administration of study intervention administration until 2 weeks after the study Follow-up Visit.
Have a BMI between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. 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 approved.
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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA 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 research environment Vivli.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 |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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|
| Ticagrelor | Drug | Participants in each arm will receive ticagrelor 90 mg orally BID from Day 6 to Day 10. |
|
|
To assess the effect of ticagrelor on the PK (t1/2) of rosuvastatin in healthy participants.
| From Day 1 to Day 11 |
| Terminal rate constant (parent only) (λz) | To assess the effect of ticagrelor on the PK (λz) of rosuvastatin in healthy participants. | From Day 1 to Day 11 |
| Time to reach maximum observed concentration (tmax) | To assess the effect of ticagrelor on the PK (tmax) of rosuvastatin in healthy participants. | From Day 1 to Day 11 |
| Amount of drug excreted (Ae) | To assess the effect of ticagrelor on the urine PK (Ae) of rosuvastatin in healthy participants. | From Day 1 to Day 11 |
| Renal clearance (Clrenal) | To assess the effect of ticagrelor on the urine PK (Clrenal) of rosuvastatin in healthy participants. | From Day 1 to Day 11 |
| Percent of dose excreted | To assess the effect of ticagrelor on the urine PK of rosuvastatin in healthy participants. | From Day 1 to Day 11 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |