NCT04332523 is a Phase 1 clinical trial of JNJ-53718678 in Hepatic Impairment, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT04332523?

NCT04332523 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT04332523?

Interventions in NCT04332523: JNJ-53718678.

What condition does NCT04332523 study?

NCT04332523 studies Hepatic Impairment.

Is NCT04332523 still recruiting?

NCT04332523 is currently terminated. Last updated 13 June 2022.

Last reviewed 2022-06-13 · How we verify

NCT04332523

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of JNJ-53718678 in Participants With Hepatic Impairment

Terminated Phase 1 Last updated 13 June 2022

What this trial tests

Phase 1 trial testing JNJ-53718678 in Hepatic Impairment in 25 participants. Terminated before completion.

Timeline

17 August 2020

Primary endpoint
16 March 2022

16 March 2022

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	17 August 2020
Primary completion	16 March 2022
Estimated completion	16 March 2022
Sites	2 locations across United States

Drugs / interventions tested

JNJ-53718678 — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 75, any sex, with Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants with normal hepatic function.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Probing In Silico the Benzimidazole Privileged Scaffold for the Development of Drug-like Anti-RSV Agents.
Cichero E, Calautti A, Francesconi V, Tonelli M, et al · · 2021 · cited 22× · PMID 34959708 · DOI 10.3390/ph14121307
Advances in development of antiviral strategies against respiratory syncytial virus.
Yang G, Jiang G, Jiang J, Li Y. · · 2025 · cited 4× · PMID 40486844 · DOI 10.1016/j.apsb.2025.02.015

Verify or expand the search:

Other trials of JNJ-53718678

Trials testing the same drug.

NCT04090086 — A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Particip · Phase 1 · completed
NCT03656510 — Study to Evaluate Safety and Antiviral Activity of Doses of JNJ-53718678 in Children (>=28 Days to <=3 Years) With Respi · Phase 2 · terminated
NCT03002779 — A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Health · Phase 1 · completed
NCT02945007 — A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-53718678 Administered as Oral Concept Formul · Phase 1 · completed
NCT02593851 — A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 i · Phase 1 · terminated

Other recruiting trials for Hepatic Impairment

Currently open trials in the same condition.

NCT07269301 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function · Phase 1 · recruiting
NCT07219550 — A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017) · Phase 1 · recruiting
NCT07144111 — A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib · Phase 1 · recruiting
NCT07023354 — A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems · Phase 1 · recruiting
NCT06985615 — A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement · Phase 1 · recruiting

Other Janssen Research & Development, LLC trials

Trials by the same sponsor.

NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04332523 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
Last refreshed: 13 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04332523.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing