A Study of JNJ-73763989 in Adult Participants With Renal Impairment

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-73763989 in Adult Participants

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: JNJ-73763989


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have stable renal function defined as a less than (<) 20 percent (%) change in serum creatinine concentrations between screening and Day -1 Concomitant medications should be stable for the previous 1 month and throughout the duration of the study Women, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine (beta-hCG) pregnancy test on Day -1 Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for the study and are willing to participate in the study Participants with kidney disease without dialysis using benzodiazepines, tricyclic antidepressants, and prescription opiates with a positive urine test for drugs prescribed by their physician may be included following prior discussion with the sponsor Exclusion Criteria: Have kidney disease requiring dialysis Renal transplants, systemic lupus erythematosus, or participant with malignancy Known allergies, hypersensitivity, or intolerance to JNJ-73763989 or its excipients Received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the administration of the study drug is scheduled Preplanned surgery or procedures that would interfere with the conduct of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: JNJ-73763989<br>Participants with moderate renal impairment will receive a single subcutaneous (SC) injection of JNJ-73763989 on Day 1. | Drug: JNJ-73763989<br>* JNJ-73763989 will be administered as a single SC injection.<br>|
| Experimental: Group 2: JNJ-73763989<br>Participants with severe renal impairment or end-stage renal disease (ESRD) will receive a single SC injection of JNJ-73763989 on Day 1. | Drug: JNJ-73763989<br>* JNJ-73763989 will be administered as a single SC injection.<br>|
| Experimental: Group 3: JNJ-73763989<br>Participants with normal renal function will receive a single SC injection of JNJ-73763989 on Day 1. | Drug: JNJ-73763989<br>* JNJ-73763989 will be administered as a single SC injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Predose, up to 72 hours postdose (up to Day 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 42 days |