The main purpose of this study is to evaluate the pharmacokinetics of JNJ-64417184, JNJ-68294291, and JNJ-65201526 after a single oral dose of JNJ-64417184 in adult participants with various degrees of impaired renal function (moderate \[optional\], severe renal impairment, and end stage renal disease (ESRD) not requiring hemodialysis) compared to participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
6
Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
APEX GmbH
München, Germany
Maximum Observed Plasma Analyte Concentration (Cmax) of JNJ-64417184and its Metabolites (JNJ-68294291 and JNJ-65201526)
Cmax is defined as maximum observed plasma analyte concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose
Area under the Plasma Analyte Concentration Time Curve from Time 0 to Time of the Last Measurable Concentration [AUC (0-Last)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526)
AUC (0-Last) is defined as area under the plasma analyte concentration time curve from time 0 to time of the last measurable (non-below quantification limit \[BQL\]) concentration of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose
Area Under the Plasma Analyte Concentration Time Curve from Time 0 to Infinite Time [AUC (0-Infinity)] of JNJ-64417184 and its Metabolites (JNJ-68294291 and JNJ-65201526)
AUC (0-infinity) is defined as area under the plasma analyte concentration time curve from time 0 to infinite time, calculated as AUC (last) plus C(last)/(lambda)z, where C (last) is the last observed measurable (non-BQL) plasma analyte concentration; extrapolations of more than 20 percent (%) of the total AUC (that is, percent AUC (infinity), extrapolations greater than \[\>\] 20%) are reported as approximations of JNJ-64417184 and its metabolites (JNJ-68294291 and JNJ-65201526).
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 120 and 216 hours post dose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Day 11