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 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT03918967
Eligibility Criteria:
Inclusion Criteria:
* body mass index (BMI) ≥18.0 and ≤30.0 kg/m2
Exclusion Criteria:
* Clinically significant allergic reactions
* Gastrointestinal, renal, hematological, metabolic, neurologic or pulmonary diseases classified as significant by the Investigator
* Hepatic dysfunction upper limit of normal laboratory range
* Cardiac history or presence
* History or any concomitant active malignancy
* A known infection with human immunodeficiency virus, hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Inherited bleeding diathesis or coagulopathy with the risk of bleeding
* Hemoptysis, thrombotic or hemorrhagic event
* Cerebral vascular accident, transient ischemic attack, or subarachnoid hemorrhage
* History and/or sign/symptoms of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
* Lactose intolerance (lactase deficiency) and glucose-galactose malabsorption
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT03918967
Study Brief:
Protocol Section:
NCT03918967