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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT04809818
Eligibility Criteria:
Inclusion Criteria:
* Subject's body weight is ≥50 kg and BMI is within the range of 18 to 32
* Subject is a healthy volunteer.
* Subject's PT, aPTT, and TT are within the normal laboratory range.
* Subject is a nonsmoker
Exclusion Criteria:
* Subject has a current or recent history of regular alcohol consumption.
* Subjects who are enrolled in Part B and allergic to acetylsalicylic acid, other salicylates, clopidogrel, thienopyridines (eg, ticlopidine, prasugrel), apixaban or dabigatran.
* Part B Cohort 2 only: subjects who are poor metabolizers of clopidogrel (CYP2C19\*2/\*2, \*2/\*3, or \*3/\*3 genotype)
* Subject has a presence or history of coagulation abnormality.
* Subjects need to receive a surgery or clinical procedures associated with high bleeding risk.
* Subject has a history of minor bleeding episodes, eg, epistaxis, rectal bleeding, gingival bleeding.
* Subject has a history of peptic ulcer or gastrointestinal bleeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04809818
Study Brief:
Protocol Section:
NCT04809818