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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02063594
Eligibility Criteria:
Inclusion Criteria:
* Healthy, nonsmoking men and women 18 to 55 years of age
* Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
* Serum creatinine within normal range and calculated creatinine clearance of 80 mL/min/1.73 m2 or greater
Exclusion Criteria:
* Concurrent enrollment in another clinical trial or treatment with any investigational products or therapies within 30 days prior to dosing
* History of infusion reactions to liposomes, nanoparticles, monoclonal antibodies, or intravenously administered materials
* History of allergic/anaphylactoid-like reactions attributed to iodinated contrast agents or other components of the formulation
* Disturbances in normal fat metabolism, or total cholesterol greater than 240 mg/dL
* Pregnant or nursing women
* Exposure to significant radiation within 1 year, or previous CT scan within 5 years prior to check-in
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02063594
Study Brief:
Protocol Section:
NCT02063594