Clinical trials: completed, sponsored by Janssen Research & Development, LLC
Schizophrenia
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia
The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.
- Trial name
- NCT01559272
- Testing
- Paliperidone IR (Period 1), Paliperidone palmitate F015 (Panel A: treatment group 1), Paliperidone palmitate F015 (Panel A: treatment group 2)
- Where
- 36 sites in United States, Belgium and 9 more
- Volunteers
- 328 people
- Sponsor
- Janssen Research & Development, LLC
Osteoarthritis, Pain
Study of Safety, Efficacy of Fulranumab Adjunctive Use in OA of Hip or Knee, PAI3007
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of fulranumab as adjunctive therapy compared with placebo in participants with signs and symptoms of osteoarthritis of the hip or knee that are…
- Trial name
- NCT02301234
- Testing
- Fulranumab 1 mg, Fulranumab 3 mg, Celecoxib 100 mg
- Where
- 64 sites in United States, Australia and 9 more
- Volunteers
- 111 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab
The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to…
- Trial name
- NAVIGATE (NCT02203032)
- Testing
- Ustekinumab, Guselkumab
- Where
- 85 sites in United States, Australia and 8 more
- Volunteers
- 872 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
Sodium-glucose Co-transporter 2 (SGLT2) Inhibitor Risk of Below-Knee Lower Extremity Amputation: A Retrospective Cohort Study Using a Large Claims Database in the United States
The purpose of the study is to estimate the incidence of below-knee lower extremity amputation in type 2 diabetes mellitus (T2DM) participants newly exposed to sodium-glucose co-transporter 2 inhibitors (SGLT2i)/ non-SGLT2i…
- Trial name
- NCT02857764
- Volunteers
- 127,690 people
- Sponsor
- Janssen Research & Development, LLC
CD20-positive B-cell Non-Hodgkin Lymphoma
A Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With CD20-Positive B-Cell Non Hodgkin Lymphoma
The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to document responses of this combination in…
- Trial name
- NCT01569750
- Testing
- Part 1, Cohort 1, Part 1, Cohort 2, Part 1, Cohort 3
- Where
- 7 sites in United States, France
- Volunteers
- 33 people
- Sponsor
- Janssen Research & Development, LLC
Age-related Macular Degeneration
A Safety Study of CNTO 2476 in Patients With Age-Related Macular Degeneration
The main purpose of this study to evaluate the safety and tolerability of CNTO 2476 administered subretinally (beneath the retina) using the iTrack Model 275 micro catheter in patients with visual acuity (acuteness or clearness…
- Trial name
- NCT01226628
- Testing
- CNTO 2476, iTrack Model 275 micro catheter
- Where
- 2 sites in United States
- Volunteers
- 39 people
- Sponsor
- Janssen Research & Development, LLC
Pain
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain
The purpose of this study is to evaluate the safety and efficacy of R331333 (referred to as JNS024 Extended-Release (ER) or CG5503) compared with an active comparator (oxycodone Controlled Release (CR)) in Japanese and Korean…
- Trial name
- NCT01165281
- Testing
- Oxycodone CR, R331333 (referred to as JNS024 ER or CG5503)
- Where
- 52 sites in Japan, South Korea
- Volunteers
- 343 people
- Sponsor
- Janssen Research & Development, LLC
Lymphoma
A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
- Trial name
- NCT01779791
- Testing
- PCI-32765 (Ibrutinib)
- Where
- 54 sites in United States, Australia and 7 more
- Volunteers
- 110 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
The purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (XR) compared with canagliflozin alone, and metformin XR alone in patients with type 2 diabetes…
- Trial name
- NCT01809327
- Testing
- Canagliflozin 100 mg, Canagliflozin 300 mg, Metformin XR
- Where
- 129 sites in United States, Argentina and 11 more
- Volunteers
- 1,186 people
- Sponsor
- Janssen Research & Development, LLC
Psoriasis
A Study to Evaluate Safety and Efficacy of Toreforant (JNJ-38518168) in Participants With Moderate to Severe Plaque-type Psoriasis
The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-38518168 in participants with moderate to severe plaque-type psoriasis (common genetically determined, chronic, inflammatory skin disease…
- Trial name
- NCT02295865
- Testing
- JNJ-38518168 60 mg, JNJ-38518168 30 mg, JNJ-38518168 3 mg
- Where
- 13 sites in United States, Poland
- Volunteers
- 62 people
- Sponsor
- Janssen Research & Development, LLC
B-Cell Chronic Lymphocytic Leukemia
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
The purpose of this study is to assess the effect of a moderate Cytochrome P450 (CYP) 3A inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state pharmacokinetics (PK [the study of the way a drug…
- Trial name
- NCT02381080
- Testing
- Ibrutinib, Erythromycin, Voriconazole
- Where
- 6 sites in Canada, Russia and 1 more
- Volunteers
- 26 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants
The primary purpose of this study is to evaluate the effect of food on the relative bioavailability of a single 9 milligram (mg) oral dose of erdafitinib in healthy participants.
- Trial name
- NCT03066687
- Testing
- Erdafitinib
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate the Effect of Oral Doses of JNJ-54175446 on the Inhibition of Cytochrome P450 CYP3A4, CYP2C9, CYP1A2 and CYP2D6 Activity and the Induction of CYP2B6 and CYP2C19 Activity Using a Multiple Probe Substrate Cocktail in Healthy Subjects
The main purpose of this study is to determine the potential inhibitory/inducing effects of JNJ-54175446 after single and repeated dosing on the single-dose pharmacokinetics (PK) of a cocktail, containing selective probes of…
- Trial name
- NCT03058419
- Testing
- JNJ-54175446 150 mg, JNJ-54175446 600 mg, Midazolam 2 mg
- Where
- Belgium
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Characterize the Absorption, Metabolism, and Excretion of 14C-JNJ-53718678 After a Single Oral Dose in Healthy Male Participants
The purpose of the study is to determine the routes of excretion for JNJ-53718678 and its metabolites, to explore the metabolic pathways of JNJ-53718678, and to determine the chemical structure of predominant metabolites in…
- Trial name
- NCT03002779
- Testing
- JNJ-53718678
- Where
- Netherlands
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-JNJ-42847922 After a Single Oral Dose of 40 mg in Healthy Subjects
The objective of this study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of 14C-JNJ-42847922 in healthy subjects after a single oral dose of 40 milligram (mg) 14C-JNJ-42847922 containing maximally…
- Trial name
- NCT03025022
- Testing
- 14C-JNJ-42847922 40 mg
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents
The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any…
- Trial name
- NCT02636192
- Testing
- No Intervention
- Volunteers
- 200,000 people
- Sponsor
- Janssen Research & Development, LLC
Healthy
A Study to Evaluate the Pharmacokinetics and the Effect on Cardiac Repolarization of Odalasvir Administered as a Single Dose Tablet Under Fed Conditions in Healthy Participants
The purpose of this study is to determine the relationship between the plasma concentrations of odalasvir and changes in the QT interval / QTc interval (QT corrected for heart rate) using exposure-response (ER) analysis.
- Trial name
- NCT02889367
- Testing
- Odalasvir 100 mg, Odalasvir 500 mg, Odalasvir (Up to maximum 1000 mg)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule
The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
- Trial name
- NCT02877225
- Testing
- Ibrutinib, IMBRUVICA
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Arthritis, Rheumatoid
A Study to Evaluate the Effect of a Single Dose of CNTO 136 (Sirukumab) on CYP450 Enzyme Activities After Subcutaneous Administration in Patients With Rheumatoid Arthritis
The main purpose of this study is to evaluate the potential effects of a single dose of sirukumab on the pharmacokinetics (what the body does to a drug) of study agents that are specific for cytochrome P450 (CYP) enzymes (CYP3A4…
- Trial name
- NCT01636557
- Testing
- Sirukumab, Midazolam, Warfarin
- Where
- 5 sites in Germany, Moldova and 2 more
- Volunteers
- 12 people
- Sponsor
- Janssen Research & Development, LLC
Diabetes Mellitus, Type 2
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Canagliflozin in Older Children and Adolescents With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the pharmacokinetics (blood levels) and pharmacodynamics (the action or effects a drug has on the body) of canagliflozin in children and adolescents with type 2 diabetes mellitus aged 10…
- Trial name
- NCT02000700
- Testing
- Canagliflozin 100 mg, Canagliflozin 50 mg, Canagliflozin 300 mg
- Where
- 17 sites in United States, Brazil
- Volunteers
- 17 people
- Sponsor
- Janssen Research & Development, LLC