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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT04426357
Eligibility Criteria:
Inclusion Criteria:
* Participants with normal renal function:
must have normal renal function defined as: estimated glomerular filtration rate (eGFR) greater than or equal to (\>=) 90 milliliter per minute per 1.73 meter square (mL/min/1.73 m\^2 (calculated by the modification of diet in renal disease \[MDRD\] formula)
* Healthy on the basis of physical examination, medical and surgical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participants with moderate or severe renal impairment:
must meet the following additional inclusion criteria to be enrolled in the study: must be otherwise healthy except for the renal impairment and its underlying disease states and mild comorbidities and participant must be medically stable on the basis of physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening. If there are abnormalities or results outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Participants with end stage renal disease (ESRD): must have a hematocrit at screening of greater than or equal to (\>=) 30 percent (%)
* Must not smoke more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3 months prior to screening until the end of the study
Exclusion Criteria:
* History of any illness (unrelated to renal impairment or its underlying disease, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include but is not limited to history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology, chronic skin disease, or history of mental disease
* Known allergies, hypersensitivity, or intolerance to JNJ-64417184 or any of its excipients
* Past history of clinically significant cardiac arrhythmias (example, extrasystole, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
* Any evidence of clinically significant heart block or bundle branch block at screening
* Current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
* History of hepatitis A, B, or C infection, or current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by hepatitis B surface antigen), or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04426357
Study Brief:
Protocol Section:
NCT04426357