Status:
COMPLETED
A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects
Lead Sponsor:
Viatris Innovation GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 h...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2019
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT03430661
Start Date
January 24 2018
End Date
May 29 2019
Last Update
July 3 2025
Active Locations (1)
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1
Biotrial Inc
Newark, New Jersey, United States, 07103