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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT05546957
Eligibility Criteria:
Key Inclusion Criteria:
1. Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed during screening
3. Is in good health based on laboratory safety testing obtained at the screening visit
4. Willing and able to abstain from alcohol use for the duration of the study
Key Exclusion Criteria:
1. History of anemia, abnormal bleeding (including vaginal bleeding or excessive menstrual periods), previous diagnosis of bleeding diathesis, or blood clots as defined in the protocol
2. History, in the last year, of any bleeding GI lesions such as peptic ulcer, hemorrhoids or anal fissure, or a positive fecal occult blood test performed either during screening or on Day 1
3. Presence of irregular stool patterns, constipation, or frequent diarrhea that, in the opinion of the investigator, may interfere with stool collections required by the protocol
4. Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc.
5. Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal
6. PT and aPTT values above the upper limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal
7. Platelet count below the lower limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal
8. History of clinically significant respiratory, hepatic, renal, GI, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation.
History of any atherosclerotic cardiovascular disease
9. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
10. Has received a COVID-19 vaccination within 1 week of day 1 of the study or for which the planned COVID-19 vaccinations would not be completed 1 week prior to day 1 of the study.
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05546957
Study Brief:
Protocol Section:
NCT05546957