Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
- Trial name
- NCT06894212
- Testing
- SEP-363856
- Where
- 73 sites in United States, Japan
- Volunteers
- 538 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, Multidrug-Resistant, Tuberculosis
Linezolid Dosing Strategies in Drug-Resistant TB
The purpose of the study was to evaluate the efficacy (how well the medicines work) and tolerability (whether participants stop treatment because of side effects from a drug) of an anti-TB treatment regimen that compared two…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Tuberculosis, Pulmonary
- Trial name
- NCT05007821
- Testing
- Linezolid 600 mg, Linezolid 1200 mg (QD), Linezolid 1200 mg (TIW)
- Where
- 13 sites in Botswana, Brazil and 5 more
- Volunteers
- 138 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia
This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.
- Trial name
- NCT03896945
- Testing
- AVP-786
- Where
- 72 sites in United States, Bulgaria and 2 more
- Volunteers
- 136 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Acute Schizophrenia
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
Confirm the efficacy of the brexpiprazole QW formulation versus placebo for acute symptoms of schizophrenia
- Trial name
- NCT05325645
- Testing
- OPC-34712FUM/ Brexpiprazole fumarate
- Where
- Japan
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
PARKINSON DISEASE (Disorder), Apathy
Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy
This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation).
- Conditions
- PARKINSON DISEASE (Disorder), Apathy, Safety
- Trial name
- LIFT-PD (NCT07461220)
- Testing
- IRL757
- Where
- 14 sites in Bulgaria, Germany and 2 more
- Volunteers
- 75 people
- Sponsor
- Integrative Research Laboratories AB
Healthy Volunteers
A Brain Imaging Study to Assess the Binding of MSP-2020 to Serotonin 5-HT2A Receptors in Healthy Male Adults
This study is to see how well MSP-2020 attaches to specific targets in the brain called serotonin type 2A receptors (5-HT2AR). This study will also look at how much of the study drug (and its metabolite) is in the blood and how…
- Trial name
- NCT07329621
- Testing
- MSP-2020
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Pulmonary TB
Safety and Efficacy Evaluation of 4-month Regimen of OPC-167832, Delamanid and Bedaquiline in Participants With Drug-Susceptible Pulmonary TB
This trial will assess the safety and efficacy of OPC-167832 combined with delamanid and bedaquiline in participants with drug-susceptible tuberculosis (DS-TB) administered for 17 weeks compared to rifampin, isoniazid…
- Trial name
- NCT05221502
- Testing
- Delamanid, Bedaquiline, RHEZ
- Where
- 6 sites in South Africa
- Volunteers
- 122 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together
The purpose of this study is to assess the drug-drug interaction (DDI) of repinatrabit with ethinyl estradiol/norethindrone or norethisterone (EE/NE), metformin, rosuvastatin, carbamazepine, and methotrexate in healthy…
- Trial name
- NCT07446400
- Testing
- Repinatrabit, EE/NE, Metformin
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Phenylketonuria
A Trial to Examine if Repinatrabit is Processed Differently in Adults With Reduced Liver or Kidney Function Compared to Adults With Normal Liver and Kidney Function
This trial is intended to understand how the body processes repinatrabit in people with moderate liver impairment and severe kidney impairment and also to compare these results with people of similar age, weight, and sex who have…
- Trial name
- NCT07713758
- Testing
- Repinatrabit
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder, Behavioral Symptoms
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
This study will provide long-term safety data for patients who are taking aripiprazole for up to 1 year. Most patients enrolled in this study will have participated in a short-term study with aripiprazole (CN138-178 [NCT00332241]…
- Trial name
- NCT00365859
- Testing
- Aripiprazole
- Where
- 55 sites in United States
- Volunteers
- 330 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA)
A Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of VIS171 in Participants With Autoimmune Disease(s)
The purpose of this trial is to measure safety and tolerability of subcutaneous (SC) VIS171 in combination with standard of care in participants with autoimmune disease(s).
- Conditions
- Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA), Immune-mediated Focal Segmental Glomerulosclerosis (FSGS)
- Trial name
- NCT06799520
- Testing
- VIS171
- Where
- 6 sites in Bulgaria, Moldova and 2 more
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Phenylketonuria
First-in-Human, Multiple Part Clinical Study of JNT-517 in Healthy Participants and in Participants With Phenylketonuria
The goal of Parts A and B of this Phase 1/2, first-in-human, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of single (SAD) and multiple (MAD) ascending doses of oral JNT-517 in healthy…
- Trial name
- NCT05781399
- Testing
- JNT-517 Suspension, JNT-517 Tablet
- Where
- 15 sites in United States, Australia
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immunoglobulin A Nephropathy
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
- Trial name
- NCT05248646
- Testing
- Sibeprenlimab 400 mg
- Where
- 308 sites in United States, Argentina and 29 more
- Volunteers
- 530 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremias, Water Intoxication
"SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia
This study's purpose is to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal, and to characterize and quantify the potential clinical benefits of this treatment.
- Conditions
- Hyponatremias, Water Intoxication, Inappropriate ADH Syndrome, Water-Electrolyte Imbalances
- Trial name
- NCT00072683
- Testing
- tolvaptan
- Where
- 23 sites in United States
- Volunteers
- 205 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
A Switch Study of BMS-337039 in Schizophrenic Out-patients
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general…
- Trial name
- NCT00232687
- Testing
- Aripiprazole
- Where
- 72 sites in Austria, Belgium and 8 more
- Volunteers
- 450 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
A Study of Adjunctive Aripiprazole in Participants With Major Depressive Disorder
This trial is a 14 week, randomized, double-blind, placebo controlled study, to assess the safety and efficacy of aripiprazole as adjunctive treatment to an ongoing antidepressant treatment in patients with Major Depressive…
- Trial name
- NCT00095758
- Testing
- Antidepressant + Aripiprazole
- Where
- 28 sites in United States
- Volunteers
- 1,151 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Hyponatremia
Study of Ascending Levels of Tolvaptan in Hyponatremia
The purpose of this study was to determine whether tolvaptan can safely and effectively return the body's balance of sodium and water toward normal and to characterize and quantify the potential clinical benefits of this…
- Trial name
- SALT2 (NCT00201994)
- Testing
- Tolvaptan
- Where
- Germany
- Volunteers
- 243 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Tuberculosis, HIV Infections
Evaluating the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
This Phase I/II study evaluated the pharmacokinetics, safety, and tolerability of the anti-tuberculosis (TB) drug delamanid (DLM) in combination with an optimized multidrug background regimen (OBR) for multidrug-resistant…
- Trial name
- NCT03141060
- Testing
- Delamanid, Optimized multidrug background regimen (OBR) for children with MDR-TB
- Where
- 5 sites in India, South Africa and 1 more
- Volunteers
- 37 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Keratoconjunctivitis Sicca
Study of Rebamipide Eye Drops to Treat Dry Eye
The purpose of this study is to determine the potential safety and effectiveness of rebamipide eye drops, an investigational eye drop being developed for the treatment of keratoconjunctivitis sicca (dry eye).
- Trial name
- NCT00201955
- Testing
- Rebamipide 1%, Rebamipide 2%
- Where
- 60 sites in United States
- Volunteers
- 762 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.