Renal Impairment
Conditions
Brief summary
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.
Interventions
DRUGJNJ-73763989
JNJ-73763989 will be administered as a single SC injection.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of JNJ-73763989 | Predose, up to 72 hours postdose (up to Day 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to 42 days | 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. |
| Number of Participants with AEs by Severity Grades | Up to 42 days | 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. |
| Number of Participants with Abnormalities in Clinical Laboratory Tests, Electrocardiograms (ECGs), Vital Signs and Physical Examination | Up to 42 days | 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. |
Countries
Germany
Outcome results
None listed