The purpose of study is to evaluate the pharmacokinetics of a single, subcutaneous dose of JNJ-64565111 in adult participants with varying degrees of renal function including participants with end stage renal disease, requiring hemodialysis, compared with participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.
Orlando Clinical Research Center
Orlando, Florida, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, United States
Maximum Observed Serum Analyte Concentration (Cmax) of JNJ-64565111
Cmax is the maximum observed serum analyte concentration of JNJ-64565111.
Time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose
Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Last Measurable (not Below Quantification Limit) Concentration (AUC[0-last]) of JNJ-64565111
AUC \[0-Last\] is the area under the serum analyte concentration versus time curve from time zero to the time of the last measurable (not below quantification limit) concentration of JNJ-64565111, calculated by linear-linear trapezoidal summation.
Time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose
Area Under the Serum Analyte Concentration-Time Curve from Time Zero to Infinite Time (AUC[0-infinity]) of JNJ-64565111
AUC (0-infinity) is the area under the serum analyte concentration-time curve from time zero to infinite time, calculated as AUC(last) + C(last)/lamda(z) where C(last) is the last observed measurable (not below quantification limit) concentration of JNJ-64565111.
Time frame: Predose, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 984 hours postdose
Number of Participants with Antibodies to JNJ-64565111
Number of participants with antibodies to JNJ-64565111 will be reported.
Time frame: Predose, Days 7, 29 and 42
Number of Participants with Adverse Events
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily have a causal relationship with the relevant investigational product.
Time frame: Approximately 9 weeks
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