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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT02596100
Eligibility Criteria:
Inclusion Criteria:
* All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.
* A healthy man or woman between the ages of 18 and 60
* Has no clinically significant findings in medical history, physical examination, EKG and vital signs
* Weighs \> 45 kg (99 lbs.) and has body mass index (BMI) \< 30 kg/m2
* Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods
* Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods
Exclusion Criteria:
* None of the exclusion criteria may be present for enrollment
* Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation
* Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug
* History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug
* History of alcohol abuse (greater than 3 alcoholic beverages per day)
* Positive screen for drugs of abuse
* Positive serology test for HIV, Hepatitis B or C
* Has any allergy or sensitivity to fXa inhibitors
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02596100
Study Brief:
Protocol Section:
NCT02596100