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

NCT ID: NCT04963738

Last Updated: 2023-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2022-10-17

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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1: JNJ-73763989

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

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

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

Group 3: JNJ-73763989

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

Group Type: EXPERIMENTAL

JNJ-73763989

Intervention Type: DRUG

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

Interventions

JNJ-73763989

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

Countries

Germany

Other Identifiers

2021-001048-85

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

73763989HPB1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR109019

Identifier Type: -

Identifier Source: org_study_id