A Study of JNJ-73763989 in Adult Participants With Renal Impairment
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Group 1: JNJ-73763989 Participants with moderate renal impairment will receive a single subcutaneous (SC) injection of JNJ-73763989 on Day 1. |
Drug: JNJ-73763989
JNJ-73763989 will be administered as a single SC injection.
|
Experimental: Group 2: JNJ-73763989 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
JNJ-73763989 will be administered as a single SC injection.
|
Experimental: Group 3: JNJ-73763989 Participants with normal renal function will receive a single SC injection of JNJ-73763989 on Day 1. |
Drug: JNJ-73763989
JNJ-73763989 will be administered as a single SC injection.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have stable renal function defined as a less than (<) 20 percent (%) change in serum creatinine concentrations between screening and Day -1
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Concomitant medications should be stable for the previous 1 month and throughout the duration of the study
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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
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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
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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:
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Have kidney disease requiring dialysis
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Renal transplants, systemic lupus erythematosus, or participant with malignancy
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Known allergies, hypersensitivity, or intolerance to JNJ-73763989 or its excipients
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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
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Preplanned surgery or procedures that would interfere with the conduct of the study
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | CRS Clinical Research Services Kiel GmbH | Kiel | Germany | 24105 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109019
- 2021-001048-85
- 73763989HPB1003