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 @ 3:20 AM
Ignite Modification Date:
2025-12-25 @ 3:20 AM
NCT ID:
NCT02205905
Eligibility Criteria:
Inclusion Criteria:
1. Male
2. 18-55 years of age (inclusive)
3. Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)
4. voluntarily consent to participate and provide written informed consent prior to start of study specific procedures
5. Willing and able to remain in the study unit for the entire duration of the confinement period
6. Willing to collect all urine and fecal samples for the duration of the study period as required
7. Will to eat entire meals and snacks provided during confinement at the research facility, and understand diet will include foods with high fiber content and possibly prune juice
8. Willing to use a waterless commode located in a designated dry room for urine and feces collection for the duration of the study period as required
9. Willing to abstain from showering for the first 72 hours following study drug administration. After the restriction is lifted, willing to provide a urine sample prior to showering for the remainder of the confinement period.
Exclusion Criteria:
1. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any condition which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results
2. Clinically significant abnormal finding on the physical exam, medical history, electrocardiogram or clinical laboratory resutls at screening
3. History or presence of allergic or adverse response to anticoagulant reversal agents or related drugs
4. Significantly abnormal diet within 4 weeks
5. Donated blood or plasma within 30 days
6. Participated in another clinical trial (randomized subjects only) within 30 days
7. Participated in a radiolabeled clinical trial within the last 12 months
8. Used any over-the-counter medication, including nutritional supplements, within 7 days
9. Used any prescription medication within 14 days prior
10. Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP enzymes such as barbiturates,phenothiazines, cimetidine, carbamazepine, etc. within 30 days
11. Smoked or used tobacco products within 60 days
12. History of substance abuse or treatment (including alcohol ) within the past 2 years
13. Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates) or cotinine at screening or check-in
14. Positive test for hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus at screening or has previously been treated for hepatitis B, hepatitis C or HIV infection
15. Has irregular bowel habits
16. Has had significant radiation exposure within the prior 12 months
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
15 Years
Maximum Age:
55 Years
Study:
NCT02205905
Study Brief:
Protocol Section:
NCT02205905