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:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
NCT ID:
NCT02022306
Eligibility Criteria:
Inclusion Criteria:
* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level \>40 IU/L
* Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.
Exclusion Criteria:
* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has an estimated creatinine clearance of \<90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02022306
Study Brief:
Protocol Section:
NCT02022306