Healthy
Conditions
Brief summary
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
Interventions
DRUGACT-246475
Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection
DRUGClopidogrel
Tablet for oral administration (300 or 600 mg)
DRUGPrasugrel
Tablet for oral administration (60 mg)
DRUGPlacebo
Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution
DRUGTicagrelor
Tablet for oral administration (180 mg)
Sponsors
Viatris Innovation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | From baseline up to 48 hours | \- IPA%\[MPA\] will be calculated as mean change in percentage from baseline for each time point. |
| 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. | From baseline up to 48 hours | \- 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). |
Countries
United States
Outcome results
None listed