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

NCT04963738 | Completed Phase 1

• 3 other identifiers: CR1090192021-001048-8573763989HPB1003
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• Number of Participants with Adverse Events (AEs)

  Up to 42 days

• Number of Participants with AEs by Severity Grades

  Up to 42 days

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

  Up to 42 days

Study Arms (3)

Group 1: JNJ-73763989

EXPERIMENTAL

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

Drug: JNJ-73763989

Group 2: JNJ-73763989

EXPERIMENTAL

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

Group 3: JNJ-73763989

EXPERIMENTAL

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

Drug: JNJ-73763989

Interventions

JNJ-73763989 DRUG

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

Group 1: JNJ-73763989; Group 2: JNJ-73763989; Group 3: JNJ-73763989

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 15, 2021
• Study Start: September 22, 2021
• Primary Completion: October 17, 2022
• Study Completion: October 17, 2022
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)