Clinical trials: completed, sponsored by Janssen Research & Development, LLC
Healthy
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult Participants
The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of intranasally administered esketamine in elderly participants (greater than equal to [>=] 75 years of age) and younger healthy adult…
- Trial name
- NCT02345148
- Testing
- Esketamine
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants
The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation in healthy elderly participants.
- Trial name
- NCT02355561
- Testing
- JNJ-54861911 (Treatment A), JNJ-54861911 (Treatment B), JNJ-54861911 (Treatment C)
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Hepatitis C Virus
Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection
The purpose of this study is to evaluate the efficacy of 6 or 8 weeks of treatment regimen containing simeprevir (SMV), daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naive (not having received treatment with any approved or…
- Trial name
- ACCORDION-1 (NCT02349048)
- Testing
- Simeprevir 150 mg, Daclatasvir 60 mg, Sofosbuvir 400 mg
- Where
- 8 sites in United States, Canada
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
The CANTATA-M (CANagliflozin Treatment and Trial Analysis - Monotherapy) Trial
The purpose of this study is to evaluate the efficacy, safety, and tolerability of 2 different doses of canagliflozin administered as monotherapy compared with placebo in patients with type 2 diabetes mellitus (T2DM) inadequately…
- Trial name
- NCT01081834
- Testing
- Canagliflozin, Sitagliptin
- Where
- 78 sites in United States, Austria and 16 more
- Volunteers
- 678 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants
The primary purpose of the study is to investigate the plasma pharmacokinetics and bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths of JNJ-54175446 (50 milligram [mg] and 100 mg…
- Trial name
- NCT02930694
- Testing
- JNJ-54175446 (capsule), JNJ-54175446 (suspension)
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Attention Deficit Disorder With Hyperactivity
Concerta (Methylphenidate) -To-Generic Switch Study
The primary purpose of this study is to identify whether, after adjustment for confounders via stratification on a propensity score and adjustment for calendar year, the combined endpoint consisting of #1 to #4 (1.
- Trial name
- NCT02730572
- Testing
- Concerta, Concerta AG formulation, Concerta EG formulation
- Volunteers
- 1,464 people
- Sponsor
- Janssen Research & Development, LLC
Schizophrenia, Schizophrenic Disorders
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
- Conditions
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox
- Trial name
- NCT00488319
- Testing
- Paliperidone ER
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 400 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (JNJ-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with…
- Trial name
- NCT00968812
- Testing
- Glimepiride, Canagliflozin (JNJ-28431754), Metformin
- Where
- 138 sites in United States, Argentina and 18 more
- Volunteers
- 1,452 people
- Sponsor
- Janssen Research & Development, LLC
End-Stage Renal Disease
A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram…
- Trial name
- NCT02289703
- Testing
- Rivaroxaban 15 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.
- Trial name
- NCT01656330
- Testing
- Rivaroxaban 20 mg twice daily, Rivaroxaban 20 mg once daily, Profilnine SD
- Where
- Belgium
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Explore the Pharmacodynamic Changes When Transitioning From Rivaroxaban to Warfarin in Healthy Volunteers
The purpose of this study is to explore the pharmacodynamic (what the drug does to the body) changes when transitioning from rivaroxaban 20 mg once daily to warfarin dosed to a therapeutic level as measured by the International…
- Trial name
- NCT01400646
- Testing
- Rivaroxaban, Warfarin, Vitamin K
- Where
- Belgium
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants
The purpose of this study is to evaluate the effect of steady-state concentrations of odalasvir (ODV), AL-335 and the combination of the 3-direct-acting anti-viral agents (3-DAA) ODV, AL-335, and simeprevir (SMV) on the…
- Trial name
- NCT02885454
- Testing
- Drospirenone/ethinylestradiol, AL-335, Odalasvir (ODV)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose…
- Trial name
- NCT02758392
- Testing
- JNJ-61178104 Intravenous, JNJ-61178104 Subcutaneous
- Where
- Belgium
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease, Inflammatory Bowel Disease
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease, IBD, Colitis
- Trial name
- NCT01369342
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 220 sites in United States, Australia and 20 more
- Volunteers
- 640 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the accuracy of a subset of the length-109 probe set panel (a genetic test) in predicting response to golimumab treatment in participants with moderately to severely active ulcerative…
- Trial name
- NCT01988961
- Testing
- Golimumab
- Where
- 45 sites in United States, Belgium and 10 more
- Volunteers
- 103 people
- Sponsor
- Janssen Research & Development, LLC
Asthma, Pulmonary Disease, Chronic Obstructive
A Study for Disease Profiling of Asthma and Chronic Obstructive Pulmonary Disease
The purpose of this study is to characterize the clinical, physiologic, and molecular profiles of healthy participants, participants with mild, moderate, and severe asthma; and participants with moderate to severe Chronic…
- Trial name
- NCT01274507
- Testing
- Medical tests
- Where
- 21 sites in United States, Canada and 6 more
- Volunteers
- 328 people
- Sponsor
- Janssen Research & Development, LLC
Autism Spectrum Disorder
Study to Assess the Janssen Autism Knowledge Engine in Participants With Autism Spectrum Disorder and in a Normally Developing Cohort
The purpose of this study is to evaluate the utility of and to clinically validate the Autism Behavior Inventory (ABI) in measuring clinical symptoms of Autism Spectrum Disorder (ASD) compared with other gold standard measures.
- Trial name
- NCT02668991
- Where
- 9 sites in United States
- Volunteers
- 186 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic
A Study of Skin and Systemic Biomarkers In Patients With Active Cutaneous Lupus Erythematosus And In Healthy Volunteers
The purpose of this study is to obtain skin, blood, and urine samples from patients with active cutaneous lupus lesions and from healthy participants.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Systemic, Lupus Erythematosus, Discoid, Healthy
- Trial name
- NCT02034344
- Testing
- Skin biopsy, Blood collection, Urine collection
- Where
- 21 sites in United States, Germany and 4 more
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease, IBD
A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or…
- Conditions
- Crohn's Disease, IBD, Colitis, Inflammatory Bowel Disease
- Trial name
- NCT01369329
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 175 sites in United States, Australia and 21 more
- Volunteers
- 769 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-55375515 in healthy participants after administration of single and multiple oral doses.
- Trial name
- NCT02623491
- Testing
- JNJ-55375515
- Where
- Belgium
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC