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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT05567393
Eligibility Criteria:
Inclusion Criteria:
1\. Have a body mass index (BMI) ≥18 and ≤30.0 (kg/m\^2) at the Screening Visit.
Exclusion Criteria:
1. The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the Screening Visit. Note: Participants with positive hepatitis B virus or hepatitis C virus serology may be enrolled if quantitative polymerase chain reaction for hepatitis B virus or hepatitis C virus ribonucleic acid is negative.
2. The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the Screening Visit.
3. Heavy consumption of alcohol within 3 months before screening (\>7 drinks/week for women, \>14 drinks/week for men, where 1 drink = 5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor) or use of soft drugs (such as marijuana) within 3 months before screening, or hard drugs (such as cocaine and phencyclidine) within 1 year before Screening.
4. The participant has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 28 days before check-in (Day -1) or cotinine test is positive at Screening or Day -1.
5. The participant has had 3 incidences of vasovagal syncope within the last 5 years.
6. The participant has Brugada syndrome (right bundle branch block \[RBBB\] pattern with ST-elevation in leads V1-V3).
7. The participant has an average semirecumbent systolic blood pressure \<90 millimeters of mercury (mm Hg) or diastolic blood pressure \<60 mm Hg at Screening or admission.
8. The participant has an average heart rate (HR) \<60 or \>100 beats per minute (bpm) \[at Screening, at Day -1, or at predose\]; athletic participants with an average HR \<60 bpm can be enrolled only with medical monitor approval.
9. The participant has orthostatic hypotension defined as a decrease in systolic blood pressure ≥20 mm Hg or a decrease in diastolic blood pressure ≥10 mm Hg after 2 minutes of standing when compared with blood pressure from the sitting position at Screening, and at Day -1. Participants with postural orthostatic tachycardia, defined as HR \>120 bpm standing, will also be excluded.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05567393
Study Brief:
Protocol Section:
NCT05567393