A Study to Investigate the Interaction Between ACT-246475 and Clopidogrel, Prasugrel, and Ticagrelor in Healthy Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/2/2018 |
| Start Date: | January 24, 2018 |
| End Date: | June 30, 2019 |
| Contact: | ClinicaL Trial Disclosure desk |
| Email: | clinical-trials-disclosure@idorsia.com |
| Phone: | +41 58 844 00 00 |
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
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
clopidogrel, prasugrel, and ticagrelor when administered after a single subcutaneous (s.c.)
dose of ACT-246475 in healthy male and female subjects
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
We found this trial at
1
site
Click here to add this to my saved trials
