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The main purpose is to study the pharmacokinetics of selatogrel (ACT-246475) using different administration modes and formulations. The clinical pharmacology data will be used to support demonstration of bioequivalence and interchangeability of the different formulations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: liquid formulation via auto-injector | Experimental | Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an auto-injector forming an integral ready-to-use single-dose drug delivery system. |
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| Treatment B: liquid formulation via syringe | Experimental | Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe. |
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| Treatment C: lyophilizate-based formulation via syringe | Experimental | Selatogrel will be administered as a reconstituted lyophilizate-based formulation for injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selatogrel | Combination Product | A single subcutaneous injection of 16 mg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t) of selatogrel | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. | |
| The area under the plasma concentration-time curve from zero to infinity (AUC0-inf) of selatogrel | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. | |
| The maximum plasma concentration (Cmax) of selatogrel | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. | |
| Time to reach Cmax (tmax) | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. | |
| Terminal half-life (t½) of selatogrel | Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in systolic and diastolic supine blood pressure | Multiple predefined times on Day 1 (pre-dose) up to Day 3. | |
| Change from baseline in pulse rate | Multiple predefined times on Day 1 (pre-dose) up to Day 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc | Overland Park | Kansas | 66212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34961905 | Result | Zenklusen I, Hsin CH, Schilling U, Kankam M, Krause A, Ufer M, Dingemanse J. Transition from Syringe to Autoinjector Based on Bridging Pharmacokinetics and Pharmacodynamics of the P2Y12 Receptor Antagonist Selatogrel in Healthy Subjects. Clin Pharmacokinet. 2022 May;61(5):687-695. doi: 10.1007/s40262-021-01097-9. Epub 2021 Dec 28. |
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| ID | Term |
|---|---|
| C000601315 | selatogrel |
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Single-center, randomized, 3-period crossover.
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| Selatogrel | Drug | A single subcutaneous injection of 16 mg. |
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| Change from baseline in body weight | Multiple predefined times on Day 1 (pre-dose) up to Day 3. |
| Change from baseline in the electric activity of the heart (12-lead electrocardiogram) | Changes in the PQ-, PR-, RR-, and QRS-interval will be measured. In addition, the QTc-interval corrected for heart rate using Bazett's (QTcB) and Fridericia's formula (QTcF) will be assessed. | Multiple predefined times on Day 1 (pre-dose) up to Day 3. |
| Change from baseline in coagulation laboratory tests | Blood samples will be taken under fasted conditions and the following tested: prothrombin time and international normalized ratio, as well as activated partial thromboplastin time. | Multiple predefined times on Day 1 (pre-dose) up to Day 3. |
| Change from baseline in clinical chemistry tests | Blood samples will be taken under fasted conditions and the following tested: aspartate aminotransferase / alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, total and direct bilirubin, lactate dehydrogenase; creatinine, urea; urate; glucose; cholesterol, triglycerides; sodium, potassium, chloride, calcium; protein, albumin. | Multiple predefined times on Day 1 (pre-dose) up to Day 3. |
| Change from baseline in clinical hematology tests | Blood samples will be taken under fasted conditions and the following tested: hemoglobin, hematocrit, erythrocytes, leukocytes; as well as a differential blood count (including basophils, eosinophils, neutrophils, lymphocytes and monocytes); and platelets. | Multiple predefined times on Day 1 (pre-dose) up to Day 3. |