Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT03430661
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03430661
Study Brief:
Protocol Section:
NCT03430661