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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04963738
• Other study ID #: CR109019
• Secondary ID: 2021-001048-8573
• Status: Completed
• Phase: Phase 1
• Start date: September 22, 2021
• Est. completion date: October 17, 2022

Study information

• Verified date: November 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 17, 2022
• Est. primary completion date: October 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• JNJ-73763989
JNJ-73763989 will be administered as a single SC injection.

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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