The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of JNJ-73763989 in adult participants with renal impairment compared with healthy participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
29
JNJ-73763989 will be administered as a single SC injection.
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
Plasma Concentration of JNJ-73763989
Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924) using a validated and qualified method.
Time frame: Predose, up to 72 hours postdose (up to Day 4)
Number of Participants with Adverse Events (AEs)
AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 42 days
Number of Participants with AEs by Severity Grades
Number of participants with AEs by severity grade will be reported. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 42 days
Number of Participants with Abnormalities in Clinical Laboratory Tests, Electrocardiograms (ECGs), Vital Signs and Physical Examination
Number of participants with abnormalities in clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, urinalysis, and urine chemistry), ECGs, vital signs (such as blood pressure, pulse/heart rate, body temperature \[tympanic\]) and physical examination (including height, body weight, and skin examination) will be reported.
Time frame: Up to 42 days
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