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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04097405
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be medically documented as healthy at physical examination
* Moderate smokers or non-smokers
* Subjects must be between the ages of 18 and 60
* Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
* Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
* Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater
* Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration
* Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration
* Subjects must have a complete blood count and platelet count within the normal range
* Subjects must have a normal urinalysis
* Subjects must have a normal estimated glomerular filtration rate
* Subjects must have a normal ECG
* Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures
* Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
Exclusion Criteria:
* Subjects with any history or clinical manifestations of disorders
* Subjects who have any history or suspicion of kidney stones
* Subjects who are HIV, Hep B or Hep C positive
* History of significant allergic reactions to any drug
* Clinically significant ECG abnormalities
* History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening
* Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1
* Positive urine drug screen, alcohol breath at screening
* Subjects had undergone major surgery within 3 months
* Women who are pregnant or breastfeeding
* History of significant alcohol abuse
* Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.
* Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk
* Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose
* Donation of plasma within 7 days prior to dosing
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04097405
Study Brief:
Protocol Section:
NCT04097405