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Ticagrelor granule · 1 trial · 1 indication
* To determine the relative bioavailability of ticagrelor granule for oral suspension and the pediatric ticagrelor tablet to the commercial ticagrelor tablet in healthy subjects. * To determine the relative bioavailability of ticagrelor pediatric tablet taken whole and the pediatric tablet dispersed in water to the granule for oral suspension in healthy subjects. * To evaluate the bioequivalence between the pediatric ticagrelor tablet taken whole and the pediatric ticagrelor tablet dispersed in water in healthy subjects.
* To determine the relative bioavailability of ticagrelor granule for oral suspension and the pediatric ticagrelor tablet to the commercial ticagrelor tablet in healthy subjects. * To determine the relative bioavailability of ticagrelor pediatric tablet taken whole and the pediatric tablet dispersed in water to the granule for oral suspension in healthy subjects. * To evaluate the bioequivalence between the pediatric ticagrelor tablet taken whole and the pediatric ticagrelor tablet dispersed in water in healthy subjects.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 (ADBC) | EXPERIMENTAL | Subjects were randomized to treatment sequence ADBC: On Day 1, following an overnight fast of at least 10 hours, each subject will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet |
| Treatment Sequence 2 (BACD) | EXPERIMENTAL | Subjects were randomized to treatment sequence BACD: On Day 1, following an overnight fast of at least 10 hours, each subjects will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet |
| Treatment Sequence 3 (CBDA) | EXPERIMENTAL | Subjects were randomized to treatment sequence CBDA: On Day 1, following an overnight fast of at least 10 hours, each subjects will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet |
| Treatment Sequence 4 (DCAB) | ACTIVE_COMPARATOR | Subjects were randomized to treatment sequence DCAB: On Day 1, following an overnight fast of at least 10 hours, each subjects will receive single dose of the treatment assigned to that treatment period. A =Ticagrelor granule for oral suspension equal to 90 mg. B = Ticagrelor pediatric tablets equal to 90 mg. C= Ticagrelor pediatric tablets suspended in water equal to 90 mg. D = Ticagrelor commercial IR (1 x 90 mg) tablet |
| Name | Type | Description |
|---|---|---|
| Ticagrelor granule | DRUG | A P2Y12 receptor inhibitor provided as granule for suspension. |
| Ticagrelor pediatric tablets | DRUG | A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole. |
| Ticagrelor pediatric tablets suspended in water | DRUG | A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water. |
| Ticagrelor immediate release (IR) tablets (Commercial tablet) | DRUG | A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI |
Inclusion Criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures. 2. Healthy male and female subjects aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture. 3. Females must have a negative pregnancy test at Screening and...
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Ticagrelor granule is a granule formulation of ticagrelor, a small molecule P2RY12 negative allosteric modulator being developed by AstraZeneca PLC (ticker AZN). It is in Phase 1 clinical development for sickle cell disease, a hematology indication. The granule form is distinct from the tablet formulations of ticagrelor.
Ticagrelor granule is being studied in sickle cell disease. AstraZeneca PLC is developing it as a granule formulation, and the one registered Phase 1 trial in this program enrolled adults with sickle cell disease in Germany. The trial has completed, and the program remains in clinical development rather than approved for use.
Ticagrelor granule targets P2RY12, the platelet P2Y12 receptor. It acts as a negative allosteric modulator of that receptor. This is the same molecular target and target class associated with ticagrelor, and the granule formulation is designed to deliver the same active small molecule.
AstraZeneca PLC, which trades under the ticker AZN, is the developer of ticagrelor granule. The company is running the clinical program for the granule formulation in sickle cell disease, with the single registered Phase 1 study conducted in Germany.
Ticagrelor granule is in Phase 1 clinical development. One Phase 1 trial has been registered and it is completed, with no active trials currently listed. The drug is investigational and has not been approved for sickle cell disease or any other indication based on this program.
The registered trial is NCT03126695, titled a study to compare if the uptake of ticagrelor in the body differs when different tablets are administered. It was a completed Phase 1 study in sickle cell disease, run in Germany, with 44 enrolled participants, a randomized design, active control, and healthy volunteers allowed.