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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963738
Recruitment Status : Completed
First Posted : July 15, 2021
Last Update Posted : November 9, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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
Renal Impairment Drug: JNJ-73763989 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 22, 2021
Actual Primary Completion Date : October 17, 2022
Actual Study Completion Date : October 17, 2022
Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. Plasma Concentration of JNJ-73763989 [ Time Frame: 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 :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: 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.

  2. Number of Participants with AEs by Severity Grades [ Time Frame: 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.

  3. Number of Participants with Abnormalities in Clinical Laboratory Tests, Electrocardiograms (ECGs), Vital Signs and Physical Examination [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04963738


Locations
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Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04963738    
Other Study ID Numbers: CR109019
2021-001048-85 ( EudraCT Number )
73763989HPB1003 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: November 9, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases