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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: JNJ-73763989

Study type: Interventional

Funder types: Industry

Identifiers

NCT04963738

2021-001048-85 (EudraCT Number)

73763989HPB1003 (Other Identifier)

CR109019

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 3 patient groups

Group 1: JNJ-73763989

Experimental group

Description:

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

Treatment:

Drug: JNJ-73763989

Group 2: JNJ-73763989

Experimental group

Description:

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

Treatment:

Drug: JNJ-73763989

Group 3: JNJ-73763989

Experimental group

Description:

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

Treatment:

Drug: JNJ-73763989