Single-center, Double-blind (ACT-246475), Open-label (Clopidogrel, Prasugrel, and Ticagrelor), Placebo-controlled, Randomized, Two-way Crossover Study to Investigate the Pharmacodynamics, Safety, and Tolerability of a Single Oral Dose of Clopidogrel or, Prasugrel, or Ticagrelor When Administered After a Single Subcutaneous Dose of the P2Y12 Antagonist ACT-246475 in Healthy Male and Female Subjects

ID-076-103

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

2018-01-24

2019-05-20

2019-05-29

Completed

Early phase I

77

Main Inclusion Criteria: * Signed informed consent * Healthy male and female subjects aged between 18 and 65 years (inclusive) at screening * Body mass index of 18.0 to 31.0 kg/m2 (inclusive) at Screening * Women of childbearing potential must have a negative serum pregnancy test and use reliable birth controls from screening up to at least 30 days after last study treatment administration * Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 beats per minute (bpm) (inclusive) at screening * Healthy on the basis of physical examination, cardiovascular assessments, and laboratory tests * Maximum (at peak) platelet aggregation ≥ 40% (light transmission aggregometry \[LTA\]) upon 20 μM adenosine diphosphate (ADP) activation at screening * Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for both cartridges of collagen/adrenaline and collagen/ADP below the upper limit of normal range at screening Main Exclusion Criteria: * Pregnant or lactating women * Known hypersensitivity to ACT-246475, clopidogrel, prasugrel, ticagrelor, any of their excipients, or drugs of the same class * Any contraindication to clopidogrel, prasugrel, or ticagrelor treatment * Known hypersensitivity or allergy to natural rubber latex * Platelet count \< 120 × 109 L-1 at Screening and Day -1 * Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect) * Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs, P2Y12 receptor antagonists, or any medication with blood-thinning activity (i.e., injectable or oral anticoagulants) within 3 weeks prior to study treatment administration * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

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2022-11-16