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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT03163550
Eligibility Criteria:
Key Inclusion Criteria:
* Females of child-bearing potential must not be breast feeding, must have a negative serum pregnancy test, and must use a highly effective method of contraception or be abstinent from sexual activity prior to the first dose of study, during the study and for a specified period following the last dose of study drug
* Males must be willing to use a condom for the duration of the study and for a specified period following the study, unless surgically sterile. In addition, their female partner must use a highly effective method of contraception, for the same period of time, unless surgically sterile
* Body mass index (BMI) of ≥19 kg/m\^2 to ≤32 kg/m\^2 and weight ≥50 kg to ≤125 kg
* Normal renal function as determined by creatinine clearance (CLcr) rate
Key Exclusion Criteria:
* Pregnant women
* History of any hepatic or biliary disorder or disease
* Any condition that could possibly affect oral drug absorption
* Unstable cardiovascular disease
* Uncontrolled hypertension, asthma, diabetes, thyroid disease, or seizure disorder
* HIV positive
* Active malignancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03163550
Study Brief:
Protocol Section:
NCT03163550