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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02540668
Eligibility Criteria:
Inclusion Criteria:
* Male participants: will be sterile (including vasectomy) or agree to use an effective method of birth control and will not donate sperm during the study and for 3 months following the last dose of the investigational product
* Female participants: women not of childbearing potential
Exclusion Criteria:
* Have a history of or current, significant ophthalmic disease, as determined by the investigator or ophthalmologist
* Have vitiligo or any other clinically significant disorder of skin pigmentation as determined by the investigator or dermatologist
* Have a history or presence of significant bleeding disorders
* Have a history of gastrointestinal ulcers with hemorrhage
* Have a personal or family history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations
* Self-reported history of increased bleeding from trauma
* Have a history of major head trauma (with loss of consciousness) within the past year or minor head trauma (without loss of consciousness) within the last 3 months prior to screening
* History of major surgery within 3 months of screening
* Planned surgery within 14 days after the last day of dosing
* International Normalized Ratio (INR)/ Prothrombin Time (PT) or activated partial thromboplastin time above the normal reference range at screening
* Abnormal Protein S antigen and/or Protein C activity as determined by the investigator
* History of deep vein thrombosis and/or pulmonary embolism
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02540668
Study Brief:
Protocol Section:
NCT02540668