A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects

• Status: Completed
• Trial end date: 2019-05-29
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Idorsia Pharmaceuticals Ltd.
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticagrelor; Ticlopidine

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