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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT05309902
Eligibility Criteria:
Inclusion Criteria:
1. Male participants agree to comply with any applicable contraceptive requirements of the protocol.
2. Body mass index (BMI) greater than or equal to (\>=)18.0 and \<=32.0 kilogram per square meter (kg/m\^2) at screening.
3. Continuous non-smoker who has not used nicotine-containing products for at least 90 days prior to the first dosing, based on participant self-reporting.
4. No clinically significant history or presence of ECG findings as judged by the Investigator or designee, including each criterion as listed below:
* Normal sinus rhythm (HR between 45 bpm and 100 bpm inclusive) at screening and check-in;
* QTcF is \<=450 ms (males) or \<=470 ms (females) at screening and check-in;
* QRS interval \<=110 ms; if \>110 ms, result will be confirmed by a manual over read at screening and check-in;
* PR interval \<=220 ms at screening and check-in.
Exclusion Criteria:
1. 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. History or presence of any of the following, deemed clinically significant by the Investigator or designee:
* epilepsy, seizure, or convulsion, tremor or related symptoms;
* risk factors for Torsade de Pointes (TdP) (example, heart failure, unexplained syncope, cardiomyopathy, or family history of Long QT Syndrome);
* family history of sudden death;
* sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, symptomatic or significant cardiac arrhythmia, prolonged QTcF interval, or conduction abnormalities;
* ischemic heart disease, poorly controlled hypertension, or other cardiovascular disorder;
* T wave flattening or other abnormalities which in the opinion of the investigator or designee may interfere with the analysis of QT intervals;
* clinically significant hyper- or hypokalemia.
3. Any positive responses on the Columbia-Suicide Severity Rating Scale (C-SSRS) that in the clinical judgement of the Investigator has a risk of suicide or has made a suicide attempt in the previous 12 months prior to the first dosing.
4. Positive urine drug or alcohol results at screening or at check-in.
5. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or antibody test for hepatitis C virus (HCV).
6. Unable to refrain from or anticipates the use of:
* Any vaccines, drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing. Thyroid hormone replacement medication may be permitted if the participant has been on the same stable dose for the immediate 3 months prior to first dosing.
* Any drugs known to be significant inducers of cytochrome P450 (CYP)3A, CYP2C19, uridine 5' diphospho-glucuronosyltransferase (UGT)1A9 or (UGT)2B4 enzymes and/or P-glycoprotein (P-gp), including St. John's Wort, within 28 days prior to the first dosing. Appropriate sources (example, Flockhart TableTM) will be consulted to confirm lack of Pharmacokinetics (PK)/pharmacodynamics interaction with study drug.
7. Consumes excessive amounts, defined as greater than 4 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks or other caffeinated beverages per day.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05309902
Study Brief:
Protocol Section:
NCT05309902