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 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT03723395
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) between 18 and 32 kg/m\^2
* In good health, determined be no clinically significant findings from medical history, physical examination, and screening evaluations
* Female subjects must be of nonchildbearing potential
* Male subjects must agree to use contraception or must be surgically sterile for at least 90 days prior to enrollment
* Able to understand and sign informed consent form
Exclusion Criteria:
* Any condition affecting drug absorption (including stomach or intestinal surgery)
* Significant history of metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of hypersensitivity, intolerance, or allergy to any drug compounds, food, or other substance (unless approved by Investigator)
* Participation in a clinical study involving an investigational drug within the past 30 days
* Use or intend to any prescription medications within 28 days prior to check in
* Use of tobacco- or nicotine-containing products within 28 days prior to check in
* History of hyperbilirubinemia
* History of alcoholism or drug abuse within 2 years
* History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects
* Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03723395
Study Brief:
Protocol Section:
NCT03723395