Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 5 | PHASE3 | Etavopivat Low dose |
| Novartis AG Sponsored ADR | NVS | 4 | PHASE3 | Crizanlizumab |
| Sanofi SA Sponsored ADR | SNY | 2 | PHASE3 | PCV21, 20vPCV |
| Vertex Pharmaceuticals Incorporated | VRTX | 3 | PHASE3 | CTX001 |
| Agios Pharmaceuticals, Inc. | AGIO | 2 | PHASE2 | Mitapivat |
| Pfizer Inc. | PFE | 1 | PHASE2 | Osivelotor |
| Bristol-Myers Squibb Company | BMY | 1 | PHASE1 | BMS-986470, Famotidine, Pantoprazole |
| Fulcrum Therapeutics, Inc. | FULC | 1 | PHASE2 | Pociredir |
| Beam Therapeutics, Inc. | BEAM | 2 | PHASE1 | BEAM-101 |
| Editas Medicine, Inc. | EDIT | 2 | PHASE1 | EDIT-301 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-3405 |
| Illumina, Inc. | ILMN | 1 | - | Undisclosed |
Ticagrelor granule is an investigational small molecule being studied for use in Sickle Cell Disease. It is in Phase 1 clinical development. The drug is being evaluated to understand how it is absorbed in the body, specifically comparing different tablet formulations in patients with the condition.
Ticagrelor granule is a small molecule that targets the P2Y12 receptor, an antiplatelet agent. It works by inhibiting platelet activation and aggregation. This mechanism is being explored in the context of Sickle Cell Disease, where it may help reduce complications related to blood cell adhesion and vaso-occlusion.
Ticagrelor granule is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and potential therapeutic effects in Sickle Cell Disease.
Ticagrelor granule is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is focused on assessing how the drug is absorbed and tolerated in the body.
Ticagrelor granule has one completed clinical trial registered under NCT03126695. This Phase 1 study, titled 'A Study to Compare if the Uptake of Ticagrelor in the Body Differs When Different Tablets Are Administered,' enrolled 44 participants with Sickle Cell Disease in Germany. The trial was active-controlled and randomized.
Ticagrelor granule is a formulation of ticagrelor, an antiplatelet medication. The granule form is being developed specifically for potential use in Sickle Cell Disease, whereas ticagrelor tablets are already approved for other cardiovascular indications. The granule formulation is being studied to compare its absorption profile with other tablet forms.