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

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04963738
Collaborator
(none)
32
Enrollment
1
Location
3
Arms
11.8
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 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 :
Sep 22, 2021
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT04963738
Other Study ID Numbers:
  • CR109019
  • 2021-001048-85
  • 73763989HPB1003
First Posted:
Jul 15, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Renal Insufficiency

Study Results

No Results Posted as of Aug 3, 2022