NCT04208399 is a Phase 1 clinical trial of JNJ-56136379 in Hepatic Impairment, sponsored by Janssen Sciences Ireland UC.

Who is sponsoring NCT04208399?

NCT04208399 is sponsored by Janssen Sciences Ireland UC.

What drugs are being tested in NCT04208399?

Interventions in NCT04208399: JNJ-56136379.

What condition does NCT04208399 study?

NCT04208399 studies Hepatic Impairment.

Is NCT04208399 still recruiting?

NCT04208399 is currently completed. Last updated 20 April 2021.

Last reviewed 2021-04-20 · How we verify

NCT04208399

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

A Study to Evaluate the Effect of Hepatic Impairment on JNJ-56136379

Completed Phase 1 Last updated 20 April 2021

What this trial tests

Phase 1 trial testing JNJ-56136379 in Hepatic Impairment in 16 participants. Completed in 26 March 2021.

Timeline

9 January 2020

Primary endpoint
26 March 2021

26 March 2021

Quick facts

Lead sponsor	Janssen Sciences Ireland UC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	9 January 2020
Primary completion	26 March 2021
Estimated completion	26 March 2021
Sites	1 location across Germany

Drugs / interventions tested

JNJ-56136379 — full drug profile →

Conditions studied

Hepatic Impairment — all drugs for Hepatic Impairment →

Sponsor

Janssen Sciences Ireland UC — 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 purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of JNJ-56136379 in participants with liver cirrhosis and impaired hepatic function when compared with healthy participants with normal hepatic function and no liver cirrhosis.

Publications & conference data

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

Targeting the multifunctional HBV core protein as a potential cure for chronic hepatitis B.
Viswanathan U, Mani N, Hu Z, Ban H, et al · · 2020 · cited 80× · PMID 32818519 · DOI 10.1016/j.antiviral.2020.104917
The premise of capsid assembly modulators towards eliminating HBV persistence.
Bassit L, Amblard F, Patel D, Biteau N, et al · · 2023 · cited 19× · PMID 37477111 · DOI 10.1080/17460441.2023.2239701

Verify or expand the search:

Other trials of JNJ-56136379

Trials testing the same drug.

NCT04853524 — A Study of JNJ-56136379 in Healthy Participants · Phase 1 · withdrawn
NCT04585789 — A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus · Phase 2 · completed
NCT04439539 — A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatm · Phase 2 · completed
NCT04474210 — A Study to Evaluate the Effect of Renal Impairment on JNJ-56136379 in Adult Participants · Phase 1 · terminated
NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virolo · Phase 2 · completed

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 Sciences Ireland UC trials

Trials by the same sponsor.

NCT04208386 — A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989 · Phase 1 · completed
NCT04056611 — Effects of JNJ-53718678 in Adult and Adolescent Participants Who Had a Hematopoietic Stem Cell Transplantation and Who A · Phase 2 · terminated
NCT04129554 — A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virolo · Phase 2 · completed
NCT03982186 — A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepati · Phase 2 · completed
NCT04002752 — A Study of JNJ-73763989 in Healthy Japanese Adult Participants · Phase 1 · completed

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 NCT04208399 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Sciences Ireland UC
Last refreshed: 20 April 2021

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/NCT04208399.

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