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The purpose of this study is to assess the effect of Cyclosporine on the blood levels of Ticagrelor.
A Single-Center,Open-Label,Randomized,3-Treatment,3-Period Cross-Over Study to Investigate the Potential Effect of Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Ticagrelor and the Effect of Ticagrelor on the Pharmacokinetics, Safety, and Tolerability of Cyclosporine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | cyclosporine 600 mg+ a single oral dose of 180 mg ticagrelor |
|
| B | Experimental | single dose cyclosporine 600 mg |
|
| C | Experimental | single dose 180 mg ticagrelor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug | Oral tablets, 600 mg , single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the pharmacokinetic (PK) profile for Ticagrelor and its metabolite AR-C124910XX in terms of maximum concentration (Cmax),time to maximum concentration (tmax) and area under the concentration curve from time zero to infinity (AUC) | PK samples will be collected postdose at visits 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours |
| Description of the PK profile for Ticagrelor and its metabolite AR-C124910XX in terms of area under the concentration-time curve from time zero to the last measurable concentration (AUC(0-t)),terminal half-life (t1/2) | PK samples will be collected postdose at visit 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours |
| Description of the PK profile for AR-C124910XX : ticagrelor in terms of ratios for Cmax, AUC(0-t), and AUC | PK samples will be collected postdose at visit 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours |
| Description of the PK profile for Cyclosporine in terms of Cmax, AUC(0-t), AUC, tmax and t1/2 | PK samples will be collected postdose at visit 2,3 and 4 | PK samples will be collected postdose 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables | Baseline up to 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miriana Kujacic, MD | Molndal, Sweden AstraZeneca | Study Chair |
| Kelli Craven, MD | Overland Park US, Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24861133 | Derived | Teng R, Kujacic M, Hsia J. Pharmacokinetic interaction study of ticagrelor and cyclosporine in healthy volunteers. Clin Drug Investig. 2014 Aug;34(8):529-36. doi: 10.1007/s40261-014-0205-2. |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| ticagrelor |
| Drug |
Oral tablets, 180 mg, single dose |
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |