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 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT02180269
Eligibility Criteria:
Inclusion Criteria:
* Signed an informed consent document indicating they understand the purpose of and procedures required for the study, and are willing to participate in the study
* A man, who is sexually active with a woman of child-bearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator, and must not donate sperm during the study and for 90 days after receiving the study drug
* Body mass index between 18 and 30 kilogram (kg) per square meter
* Blood pressure (supine for 5 minutes) between 90 and 150 millimeter of mercury (mm Hg) systolic, and no higher than 90 mm Hg diastolic
* Must be healthy on the basis of physical and neurological examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening or admission (up to Day 1 predose)
Exclusion Criteria:
* History of or current liver or renal impairment, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, dermatological (at the puncture site) or metabolic disturbances
* History of spontaneous, prolonged and severe bleeding of unclear origin
* History of epilepsy or fits
* History of human immunodeficiency virus (HIV) antigen/antibody positive, or tests positive for HIV at screening
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT02180269
Study Brief:
Protocol Section:
NCT02180269