Clinical trials: sponsored by Janssen Research & Development, LLC
Healthy
A Study to Assess Nipocalimab Concentrations in Breast Milk of Healthy Lactating Women
The main purpose of this study is to assess the concentrations of nipocalimab (pharmacokinetics [PK]) in the breast milk after administration of a single dose of nipocalimab into the vein, in healthy lactating women.
- Trial name
- NCT07669077
- Testing
- Nipocalimab, Breast Milk Sampling
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) in the Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With a History of Urinary Tract Infection in the Past 2 Years
The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia…
- Trial name
- NCT04899336
- Testing
- ExPEC9V
- Where
- 374 sites in United States, Australia and 19 more
- Volunteers
- 17,797 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Extraintestinal Pathogenic Escherichia Coli Prevention
A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1).
- Trial name
- NCT03819049
- Testing
- ExPEC10V, ExPEC4V, Prevnar 13
- Where
- 29 sites in United States, Belgium and 3 more
- Volunteers
- 836 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants
The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with…
- Trial name
- NCT05112939
- Testing
- RPV LA, CAB LA
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention
A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older
The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody…
- Trial name
- Engage (NCT06134804)
- Testing
- ExPEC9V, HD quadrivalent influenza vaccine
- Where
- 41 sites in United States, Belgium and 2 more
- Volunteers
- 959 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Ulcerative Colitis
A Study to Evaluate the Effect of Ustekinumab on Cytochrome P450 Enzyme Activities Following Induction and Maintenance Dosing in Participants With Active Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate the potential effects of an intravenous (IV) induction and subcutaneous (SC) maintenance administration of ustekinumab on the pharmacokinetic (PK) of a cocktail of representative probe…
- Trial name
- NCT03358706
- Testing
- Ustekinumab IV Infusion, Ustekinumab SC Injection, Midazolam 2 mg
- Where
- 16 sites in United States, Belgium and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Reversal of the Anticoagulant Effects of Milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) (Part 1) and Recombinant Human Factor VIIa (rFVIIa) (Part 2) in Healthy Participants
The primary purpose of this study is to evaluate the reversal of the anticoagulant effects of milvexian by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa (rFVIIa) in healthy participants as…
- Trial name
- NCT04543383
- Testing
- Milvexian, 4-Factor Prothrombin Complex Concentrate (4F-PCC), Recombinant Human Factor VIIa (rFVIIa)
- Where
- Netherlands
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Dengue
A Study of JNJ-64281802 for the Prevention of Dengue Infection
The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no…
- Trial name
- NCT05201794
- Testing
- JNJ-64281802
- Where
- 38 sites in Brazil, Colombia and 7 more
- Volunteers
- 1,595 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatic Impairment
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
- Trial name
- NCT04154774
- Testing
- Apalutamide
- Where
- 4 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Safety and Tolerability Study of JNJ-72537634 in Healthy Participants
The purpose of the study is to assess the safety and tolerability of JNJ-72537634 compared with placebo in healthy participants after administration of single and multiple day doses.
- Trial name
- NCT03931447
- Testing
- JNJ-72537634
- Where
- Belgium
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of JNJ-70033093 (Milvexian) in Healthy Adult Participants
The purpose of this study is to evaluate the relative bioavailability and food effect of a single dose of milvexian administered as direct compression (DC) oral tablets and roller compacted (RC) oral tablets compared with…
- Trial name
- NCT04844424
- Testing
- Milvexian
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
A Study of Sterile Saline Infusion in Healthy Volunteers
The purpose of the study is to evaluate the influence of needle size, injected fluid volume, and rate of fluid on the degree of pain experienced by adult healthy volunteers after subcutaneous infusion of sterile saline.
- Trial name
- NCT06194578
- Testing
- Sterile Saline
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Asymptomatic Amyloid-positive
An Efficacy and Safety Study of Atabecestat in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia
The purpose of this study is to evaluate whether treatment with atabecestat slows cognitive decline compared with placebo treatment, as measured by a composite cognitive measure, the Preclinical Alzheimer Cognitive Composite…
- Trial name
- EARLY (NCT02569398)
- Testing
- Atabecestat, 5 mg, Atabecestat, 25 mg
- Where
- 128 sites in United States, Australia and 11 more
- Volunteers
- 557 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Investigate the Whole Body Distribution and Radiation Dosimetry of the Positron Emission Tomography Ligand Fluoride-18 (18F)-JNJ-64326067 in Healthy Participants
The purpose of this study is to measure the whole-body distribution and radiation dosimetry of 18F-JNJ-64326067 in healthy participants.
- Trial name
- NCT03581916
- Testing
- 18F-JNJ-64326067
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of JNJ-63733657 in Healthy Chinese Participants
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.
- Trial name
- NCT05407818
- Testing
- JNJ-63733657
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study of JNJ-42847922 (Seltorexant) in Healthy Participants
The purpose of this study is to determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an intravenous (IV) infusion dose of 14C-seltorexant.
- Trial name
- NCT05236868
- Testing
- Seltorexant
- Where
- Netherlands
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Investigate the Effect of JNJ-67953964 on Gastric Mucosal Integrity in Healthy Male and Female Participants
The main purpose of the study is to investigate the upper gastro-intestinal (GI)-related safety and tolerability in healthy participants by gastroscopy and gastric biopsies after treatment with 25 milligram (mg) JNJ-67953964 once…
- Trial name
- NCT04185051
- Testing
- JNJ-67953964
- Where
- Belgium
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Depressive Disorder, Major
Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and…
- Trial name
- NCT03014544
- Testing
- Computer- administered test battery, Examiner- administered test battery
- Where
- 20 sites in United States
- Volunteers
- 585 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Alzheimer Disease
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Subjects and Subjects With Alzheimer's Disease
The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy subjects (Part 1) and multiple ascending IV dose administrations in…
- Trial name
- NCT03375697
- Testing
- JNJ-63733657
- Where
- 7 sites in Belgium, Germany and 2 more
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants
The purposes of this study are to measure the whole-body distribution and radiation dosimetry of [18F]-JNJ-70099731 (Part A), to measure the uptake, distribution, and clearance (CL) of [18F]-JNJ-70099731 by Positron Emission…
- Trial name
- NCT04911543
- Testing
- [18F]-JNJ-70099731
- Where
- Belgium
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC