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The primary objective of this study is to assess the pharmacodynamic (PD) effects of clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.) dose of ACT-246475 in healthy male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Group 1 | Experimental | Clopidogrel will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax |
|
| Part A: Group 2 | Experimental | Clopidogrel will be administered 12 h after ACT-246475 or placebo |
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| Part A: Group 3 | Experimental | Any time interval up to 24 h between the administration of ACT-246475 or placebo and clopidogrel may be studied |
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| Part B: Group 1 | Experimental | Prasugrel will be administered 12 h after ACT-246475 or placebo |
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| Part B: Group 2 | Experimental | Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACT-246475 | Drug | Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Time-matched comparisons of IPA% (MPA) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2, treatments are defined below) following administration of ACT-246475 and its matching placebo. | - IPA%[MPA] will be calculated as mean change in percentage from baseline for each time point. | From baseline up to 48 hours |
| Time-matched comparisons of IPA %(PRU) between treatments (i.e., Treatment A1 vs A2, Treatment B1 vs B2, and treatment C1 vs C2) following administration of ACT-246475 and its matching placebo. | - IPA%[PRU] will be calculated as mean change in percentage from baseline for each time point. Treatment A1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of clopidogrel (600 mg). Treatment A2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of clopidogrel (300 mg). Treatment B1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of prasugrel (60 mg). Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of prasugrel (60 mg). Treatment C1: single s.c. dose administration of ACT-246475-matching placebo followed by a single oral dose of ticagrelor (180 mg). Treatment B2: single s.c. dose administration (16 mg) of ACT-246475 followed by a single oral dose of ticagrelor (180 mg). | From baseline up to 48 hours |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial Inc | Newark | New Jersey | 07103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33412611 | Result | Schilling U, Dingemanse J, Dobrow M, Baumann M, Riederer MA, Juif PE, Ufer M. Insights from In Vitro and Clinical Data to Guide Transition from the Novel P2Y12 Antagonist Selatogrel to Clopidogrel, Prasugrel, and Ticagrelor. Thromb Haemost. 2021 Jun;121(6):755-766. doi: 10.1055/s-0040-1721773. Epub 2021 Jan 7. |
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| ID | Term |
|---|---|
| C000601315 | selatogrel |
| D000077144 | Clopidogrel |
| D000068799 | Prasugrel Hydrochloride |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Part B: Group 3 | Experimental | Any time interval up to 24 h between the administration of ACT-246475 or placebo and prasugrel may be studied |
|
| Part C: Group 1 | Experimental | Ticagrelor will be administered 0.5 h after ACT-246475 or placebo, i.e., at the time of tmax |
|
| Part C: Group 2 | Experimental | Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied |
|
| Part C: Group 3 | Experimental | Any time interval up to 24 h between the administration of ACT-246475 or placebo and ticagrelor may be studied |
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| Clopidogrel | Drug | Tablet for oral administration (300 or 600 mg) |
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| Prasugrel | Drug | Tablet for oral administration (60 mg) |
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| Placebo | Drug | Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution |
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| Ticagrelor | Drug | Tablet for oral administration (180 mg) |
|
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010879 | Piperazines |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |