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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04486950
Eligibility Criteria:
Inclusion Criteria:
1. Continuous non-smoker who has not used nicotine- and tobacco-containing products and/or cannabis products for at least 3 months prior to dosing and throughout the study.
2. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at screening.
3. Female must be of non-childbearing potential.
Exclusion Criteria:
1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
2. Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol.
3. Have any tattoos, scars or skin issue at planned IV infusion site which could interfere with dosing.
4. History or presence of:
* Three (3) or more incidences of vasovagal syncope within the last 5 years prior to screening.
* Family history of unexplained sudden death or channelopathy.
* Brugada syndrome (that is, right bundle branch block (RBBB) pattern with ST-elevation in leads V1-V3).
* Cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion, symptomatic or significant cardiac arrhythmia, second-degree AV block type 2, third-degree AV block, prolonged corrected QT interval by Fredericia (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities;
* Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
* Any clinically significant ECG findings or medical history including: long or short QT interval with QTcF (over 450 msec or less than 360 msec), bifascicular block or QRS \>=120 msec or PR interval greater than (\>) 200 msec at screening or Day -1 pre-Hour 0.
* Documented history of sinoatrial block or sinus pause \>=3 seconds.
5. Semi-recumbent blood pressure (average of duplicate) is less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
6. Has an average semi-recumbent heart rate \<60 or \>100 beats per minute (bpm) (at screening, at Day -1 pre-Hour 0, or at pre-dose Day 1); athletic participants with an average semi-recumbent heart rate \<60 bpm can be enrolled only with medical monitor approval. If participant has heart rate \<60 bpm Investigator should obtain medical approval from Sponsor.
7. Has orthostatic hypotension defined as a decrease in systolic blood pressure \>=20 mmHg or a decrease in diastolic blood pressure \>=10 mmHg after 2 minutes of standing when compared with blood pressure from the semi-recumbent position at screening and at Day -1 pre-Hour 0. The semi-recumbent blood pressure will be an average of duplicate measurements.
8. Has postural orthostatic tachycardia, defined as an increase of 30 bpm or heart rate \>120 bpm after standing for 2 minutes.
9. Positive urine drug or alcohol results at screening or check-in.
10. Positive urine cotinine at screening or check-in.
11. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
12. Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Thyroid hormone replacement medication may be permitted if the participant has been on same stable dose for the last 3 months prior to study drug administration. After dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Hormone replacement therapy will also be allowed.
13. Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
14. Donation of blood or significant blood loss within 56 days prior to dosing.
15. Plasma donation within 7 days prior to dosing.
16. Has positive results for Coronavirus disease 2019 (COVID-19) testing at screening or check-in.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
55 Years
Study:
NCT04486950
Study Brief:
Protocol Section:
NCT04486950