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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT03507569
Eligibility Criteria:
Inclusion Criteria:
* Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemisty, serology, and urinalysis), as judged by the Investigator.
* Males and women of non-childbearing potential (WONCBP)
Exclusion Criteria:
* History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections
* Clinically significant abnormal finding from the MRI performed after the initial screening examination
* Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
* Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm
* History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
23 Years
Maximum Age:
55 Years
Study:
NCT03507569
Study Brief:
Protocol Section:
NCT03507569