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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT02207257
Eligibility Criteria:
Inclusion Criteria:
1. Adults age 18 to 65 years, inclusive
2. Laboratory values are not clinically significant
3. No clinically significant findings on 12-lead electrocardiogram
4. Body mass index (BMI) 18 to ≤ 32 kg/m2, inclusive
5. Male subjects agree to use appropriate contraception .
6. Female subjects may be post-menopausal or, if of child-bearing potential, must have a negative serum pregnancy test prior to enrollment, and must agree to use two forms of acceptable contraception for the duration of the study and for a minimum of one complete menstrual cycle or 28 days following discharge from the study.
7. Subjects must sign informed consent
Exclusion Criteria:
1. History or current evidence of clinically significant disease, liver function tests greater than the upper limit of normal (presence of Gilbert's syndrome is acceptable), QTcF \> normal (440±10 msec for males or 460±10 msec for females).
2. History of unexplained syncope
3. History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
4. History of peptic ulcer, gastrointestinal bleeding, including the mouth, within six months prior to screening
5. History of minor bleeding episodes such as epistaxis, rectal or hemorrhoidal bleeding or gingival bleeding within 1 month prior to screening
6. Personal or family history of clotting disorder or abnormality, excessive bleeding, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or history of heparin-induced thrombocytopenia
7. Females with a history of dysfunctional uterine bleeding, menorrhagia , metrorrhagia or polymenorrhea
8. Pregnant or breast-feeding
9. Males with a history of hormone therapy within 3 months prior to screening
10. Administration of any blood product or anticoagulant within 3 months prior to study entry or any non steroidal anti-inflammatory drug or cyclooxygenase inhibitor within 2 weeks prior to screening
11. Taking any type of chronic medication within the 4 weeks prior to study entry (use of hormonal contraceptives is acceptable)
12. Positive serologic test for HIV, HCV-Ab, or HBsAG
13. Donation of blood or blood products within 56 days prior to screening
14. Smokers or use of tobacco and/or nicotine containing products within 3 months prior to dosing as determined by the subject's verbal history
15. Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
16. History of participation in any prior study of PER977 or edoxaban
17. Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02207257
Study Brief:
Protocol Section:
NCT02207257