NCT03139500 is a Phase 1 clinical trial of JNJ-61803534 in Healthy, sponsored by Janssen Research & Development, LLC.

Who is sponsoring NCT03139500?

NCT03139500 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT03139500?

Interventions in NCT03139500: JNJ-61803534, Placebo, Midazolam.

Is NCT03139500 still recruiting?

NCT03139500 is currently terminated. Last updated 20 July 2018.

Last reviewed 2018-07-20 · How we verify

NCT03139500

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

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants

Terminated Phase 1 Last updated 20 July 2018

What this trial tests

Phase 1 trial testing JNJ-61803534 in Healthy in 47 participants. Terminated before completion.

Timeline

17 May 2017

Primary endpoint
5 April 2018

5 April 2018

Quick facts

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	47
Start date	17 May 2017
Primary completion	5 April 2018
Estimated completion	5 April 2018
Sites	1 location across Belgium

Drugs / interventions tested

JNJ-61803534 — full drug profile →
Placebo
Midazolam (midazolam) — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Janssen Research & Development, LLC — full company profile →

Who can join

Adults 18 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Preclinical and clinical characterization of the RORγt inhibitor JNJ-61803534.
Xue X, De Leon-Tabaldo A, Luna-Roman R, Castro G, et al · · 2021 · cited 28× · PMID 34040108 · DOI 10.1038/s41598-021-90497-9

Verify or expand the search:

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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 NCT03139500 (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: 20 July 2018

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/NCT03139500.

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