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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT03218592
Eligibility Criteria:
Inclusion Criteria
* Healthy volunteer between the ages of 18 and 70, inclusive on the date of screening, with an intact gastrointestinal tract. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, and clinical laboratory tests
* Recent medical history in good medical standing, without evidence of fever five days prior to enrollment
* HIV-negative
* Able to swallow pills
* Has minimum hair required to provide study samples
* Not allergic to any component of the study drug
* Signed and dated informed consent indicating that they have been informed of all pertinent details of the trial and are willing to participate
* Willing and able to comply with scheduled visits, laboratory tests and trial procedures
* Willing to use at least one form of acceptable birth control throughout the duration of the study
* Negative, or receiving treatment, for syphilis at screening
* Hemoglobin Grade 2 or lower, with no clinically significant medical issues that would preclude blood sampling
Exclusion Criteria
* Age outside of desired range
* Confirmed positive results for HIV, Hepatitis B or C at screening
* Subjects of all genders actively involved in the conception process, in addition to cisgender female subjects who are in the immediate post-partum period or breastfeeding
* Insufficient amount of hair or unwilling to keep hair length at least 1 centimeter throughout duration of study
* Unable or unwilling to comply with all lifestyle measures and/or visits
* Impaired renal function, as documented by a creatinine clearance \<80 mL/min with the Cockcroft-Gault equation
* Has donated blood within the past 56 days in the amount greater than 500 mL
* Has taken an investigational drug in the past 4 months
* Clinical, laboratory, or surgical abnormalities that would preclude sample collection
* Has a condition, which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately
* Any clinically significant laboratory result Grade 2 or greater according to the Division of AIDS (DAIDS) Laboratory Grading Tables
* History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03218592
Study Brief:
Protocol Section:
NCT03218592