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 @ 1:02 PM
Ignite Modification Date:
2025-12-24 @ 1:02 PM
NCT ID:
NCT05188261
Eligibility Criteria:
Inclusion Criteria:
1. Males and female subjects of non-childbearing potential
2. Ages 18 to 60 years
3. Medically healthy with no clinically significant findings during medical evaluation including physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
4. Normal bowel movement frequency of formed stool at baseline (≥3 per week and ≤3 per day; average Bristol stool form scale (BSFS) score of \>2 and \<6).
5. Body mass index (BMI) within the range 18.5 to 35.0 kg/m2 (inclusive) at the Screening Visit.
6. Male subjects and female partners are willing to use double-barrier method of contraception during the study.
7. If subject is ≥45 years of age, subject is compliant with colorectal cancer screening guidelines according to the American College of Gastroenterology (ACG) Clinical Guidelines: Colorectal Cancer Screening 2021.
Exclusion Criteria:
1. Evidence or history of clinically significant acute or chronic disease, or clinically significant illness within 30 days of the Screening Visit.
2. History of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
3. History of any condition that would interfere with their ability to receive an enema, or has had difficulty receiving an enema in the past.
4. Recent history of anal fissure, anal abscess, complicated hemorrhoids, or presence or history of inflammatory bowel disease.
5. Used a prescription medication during the 14 days before Check-in
6. Used any over-the-counter medications, including laxatives, and herbal supplements during the 7 days before Check-in.
7. Received a licensed or investigational vaccine during the 30 days before Check-in or is planning to receive any vaccine during the study.
8. Recently received or donated blood products.
9. Undergone a surgical procedure during the 30 days before Check-in, other than minor dermatologic procedures, or has a history of surgery involving the GI tract or anal canal (with the exception of endoscopic procedures, appendectomy, and cholecystectomy).
10. Received any investigational drug during the 30 days or 5 half-lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study.
11. Abnormal laboratory tests or clinically significant findings on safety tests conducted at the Screening Visit or at Check-in.
12. Confirmed or suspected infection with COVID-19 at the Screening Visit or Check-in.
13. Positive serology for human immunodeficiency virus (HIV) 1, HIV 2, or hepatitis B surface antigen (HBsAg), or positive for anti-HIV 1, anti-HIV 2, or anti hepatitis C virus (HCV) antibodies at the Screening Visit.
14. History of alcohol or drug addiction during the year before the Screening Visit, or has a positive drug or alcohol screen at the Screening Visit or Check-in.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05188261
Study Brief:
Protocol Section:
NCT05188261