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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT02533102
Eligibility Criteria:
Inclusion criteria:
Subjects must meet all of the following criteria to be included in this study:
1. Normal healthy adult males and females (age 18-45 years).
2. Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening.
3. Pregnancy or lactation. Female patients of childbearing potential must have a negative pregnancy test before inclusion into the study, and must agree to use medically acceptable methods of contraception (eg, abstinence, condom + spermicide, or a double-barrier method \[eg, condom + diaphragm with spermicide\], or intrauterine device (IUD), or have a vasectomised partner) starting at Screening and throughout the entire study period and for 2 months after the last dose of study drug. Those female patients using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Cycle 1 Day 1, and continuing throughout the entire study period and for 2 months after the last dose of study drug. Postmenopausal women must have been amenorrheic for at least 12 consecutive months; otherwise a pregnancy test is required. Male patients must agree to use contraceptive methods (eg, abstinence, condom + spermicide or a double-barrier method \[eg, condom + partner diaphragm with spermicide\]).
4. Non-smokers.
5. Willing and able to comply with all aspects of the protocol.
6. Provide written informed consent.
Exclusion Criteria:
Participants who meet any of the following criteria will be excluded from this study:
1. Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics of study drug.
2. Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks of dosing.
3. Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history.
4. Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determinations at Screening or Baseline.
5. An interval corrected for heart rate (QTcF) interval greater than 450 msec at Screening or Baseline.
6. Females who are either pregnant or lactating.
7. A known or suspected history of drug or alcohol abuse within 6 months prior to screening, or who have a positive urine drug test or alcohol test at Screening or Baseline.
8. Positive results for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV) screen.
9. Diagnosis of acquired immune deficiency syndrome (AIDS), or positive test for human immunodeficiency virus (HIV).
10. Participation in another clinical trial less than 4 weeks prior to dosing or current enrollment in another clinical trial.
11. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week prior to dosing.
12. Hemoglobin level less than 12.0 g/dL.
13. Known history of any significant drug or food allergy or an ongoing seasonal allergy.
14. Use of prescription drugs within 2 weeks prior to Screening (unless drug has a long t1/2, ie, 5 x t1/2 exceeds 2 weeks).
15. Use of over-the-counter (OTC) medications within a minimum of 2 weeks prior to dosing.
16. Requiring a special diet or taking dietary aids known to modulate drug metabolizing enzymes, or who have consumed foods/beverages or herbal preparations containing Kava root, Ginkgo Biloba Extract (GBE), or St. John's Wort within 4 weeks of Baseline Period 1.
17. Known intolerance to the study drug (or any of the excipients).
18. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02533102
Study Brief:
Protocol Section:
NCT02533102