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NCT04426357
A Study to Evaluate the Effect of Renal Impairment on JNJ-64417184 and Its Two Minor Metabolites JNJ-68294291 and JNJ-65201526 in Adult Participants
Phase 1 trial testing JNJ-64417184 in Renal Impairment in 6 participants. Terminated before completion.
12 November 2020
Quick facts
| Lead sponsor | Janssen Pharmaceutica N.V., Belgium |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 6 |
| Start date | 3 July 2020 |
| Primary completion | 12 November 2020 |
| Estimated completion | 12 November 2020 |
| Sites | 2 locations across Germany |
Drugs / interventions tested
- JNJ-64417184
Conditions studied
- Renal Impairment — all drugs for Renal Impairment →
Sponsor
Janssen Pharmaceutica N.V., Belgium — full company profile →
Who can join
Adults 18 to 79, any sex, with Renal Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purpose of this study is to evaluate the pharmacokinetics of JNJ-64417184, JNJ-68294291, and JNJ-65201526 after a single oral dose of JNJ-64417184 in adult participants with various degrees of impaired renal function (moderate \[optional\], severe renal impairment, and end stage renal disease (ESRD) not requiring hemodialysis) compared to participants with normal renal function.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04426357
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of JNJ-64417184
Trials testing the same drug.
- NCT04453189 — A Study to Assess the Effects of Acid-Reducing Agent(s) on JNJ-64417184 in Healthy Participants · Phase 1 · completed
- NCT04258189 — A Study of JNJ-64417184, Administered as an Oral Solution, in Healthy Participants · Phase 1 · completed
- NCT04208373 — A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants · Phase 1 · completed
- NCT04121052 — A Study in Healthy Volunteers to Assess the Effect of Different Types of Food on a Single-dose of JNJ-64417184 Administe · Phase 1 · completed
- NCT04090086 — A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy Particip · Phase 1 · completed
Other recruiting trials for Renal Impairment
Currently open trials in the same condition.
- NCT07348237 — A Clinical Trial of MK-2828 in People With Kidney Disease (MK-2828-006) · Phase 1 · recruiting
- NCT07315360 — A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function · Phase 1 · recruiting
- NCT07217886 — A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls · Phase 1 · recruiting
- NCT07154901 — Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD23 · Phase 1 · recruiting
- NCT07017933 — Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes · NA · recruiting
Other Janssen Pharmaceutica N.V., Belgium trials
Trials by the same sponsor.
- NCT06544616 — A Study of JNJ-64042056 in Participants With Preclinical Alzheimer's Disease · Phase 2 · active not recruiting
- NCT05706753 — A Study of Milvexian in Healthy Adult Females · Phase 1 · completed
- NCT05550519 — A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatm · EARLY_PHASE1 · withdrawn
- NCT05552196 — A Study of Ponesimod in Healthy Adult Participants · Phase 1 · completed
- NCT05328297 — A Study of JNJ-55308942 in the Treatment of Bipolar Depression · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04426357 (US National Library of Medicine, public domain)
- 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 Pharmaceutica N.V., Belgium
- Last refreshed: 15 January 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/NCT04426357.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing