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

Primary Purpose

Renal Impairment

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

JNJ-73763989

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CRS Clinical Research Services Kiel GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1: JNJ-73763989

Group 2: JNJ-73763989

Group 3: JNJ-73763989

Arm Description

Participants with moderate renal impairment will receive a single subcutaneous (SC) injection of JNJ-73763989 on Day 1.

Participants with severe renal impairment or end-stage renal disease (ESRD) will receive a single SC injection of JNJ-73763989 on Day 1.

Participants with normal renal function will receive a single SC injection of JNJ-73763989 on Day 1.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04963738

First Posted

July 8, 2021

Last Updated

December 20, 2022

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04963738

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

September 22, 2021 (Actual)

Primary Completion Date

October 17, 2022 (Actual)

Study Completion Date

October 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Impairment

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: JNJ-73763989

Arm Type

Experimental

Arm Description

Participants with moderate renal impairment will receive a single subcutaneous (SC) injection of JNJ-73763989 on Day 1.

Arm Title

Group 2: JNJ-73763989

Arm Type

Experimental

Arm Description

Participants with severe renal impairment or end-stage renal disease (ESRD) will receive a single SC injection of JNJ-73763989 on Day 1.

Arm Title

Group 3: JNJ-73763989

Arm Type

Experimental

Arm Description

Participants with normal renal function will receive a single SC injection of JNJ-73763989 on Day 1.

Intervention Type

Drug

Intervention Name(s)

JNJ-73763989

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma Concentration of JNJ-73763989

Description

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.

Time Frame

Predose, up to 72 hours postdose (up to Day 4)

Secondary Outcome Measure Information:

Title

Number of Participants with Adverse Events (AEs)

Description

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.

Time Frame

Up to 42 days

Title

Number of Participants with AEs by Severity Grades

Description

Time Frame

Up to 42 days

Title

Number of Participants with Abnormalities in Clinical Laboratory Tests, Electrocardiograms (ECGs), Vital Signs and Physical Examination

Description

Time Frame

Up to 42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

CRS Clinical Research Services Kiel GmbH

City

Kiel

ZIP/Postal Code

24105

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing URL

https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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