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A Study of JNJ-73763989 in Adult Participants With Renal Impairment | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

An Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-73763989 in Adult Participants

NCT04963738•Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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

Locations (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Key Dates

Start Date

September 22, 2021

Primary Completion Date

October 17, 2022

Completion Date

October 17, 2022

Last Updated

November 9, 2023

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

JNJ-73763989

DRUG

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Renal Impairment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure