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 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02819102
Eligibility Criteria:
Key Inclusion Criteria:
* Written informed consent
* Body mass index 18 to 32 kg/m2
* Abides by study restrictions
* Attends all study visits and agrees to remain in study center for the confinement period
* Acceptable birth control measures for male subjects and women of childbearing potential
Key Exclusion Criteria:
* Clinically significant medical history, current medical or psychiatric condition. This includes a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, or cardiac disease
* Clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
* Poor or ultra- metabolizers of CYP2C19 or CYP2D6 Use of over the counter or prescription medication within 14 days of dosing and anticipated use through the follow-up visit
* Use of medication or consumption of any substance that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing
* Participation in any other investigational drug study within 90 days of screening
* Recent or current history of alcohol or drug abuse
* Regular recent use of tobacco or nicotine products
* Positive serology for HBV, HCV, or HIV
* Pregnant or nursing
* Donation or loss of greater than 400 mL of blood within 3 months
* Serious adverse reaction or serious hypersensitivity to any drug
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02819102
Study Brief:
Protocol Section:
NCT02819102