Clinical trials: sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Major Depressive Disorder
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment…
- Trial name
- JUNIPER (NCT05536414)
- Testing
- Centanafadine, Escitalopram
- Where
- 62 sites in United States
- Volunteers
- 337 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Attention Deficit/Hyperactivity Disorder
A Trial of Centanafadine Long-term Safety in Children and Adolescents With Attention-deficit/Hyperactivity Disorder.
To evaluate long-term safety exposure
- Trial name
- NCT05279313
- Testing
- Centanafadine Hydrochloride
- Where
- 86 sites in United States, Canada and 1 more
- Volunteers
- 680 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.
- Trial name
- NCT02477670
- Testing
- AVP-786
- Where
- 17 sites in United States
- Volunteers
- 145 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Disinhibition Syndrome
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
- Trial name
- NCT02534038
- Testing
- AVP-786
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Behavioral Symptoms, Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD)
This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00337571
- Testing
- Aripiprazole
- Where
- 31 sites in United States
- Volunteers
- 218 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Phenylketonuria (PKU)
A Phase 2 Study of JNT-517 in Adolescent Participants With Phenylketonuria
The goal of this Phase 2, randomized study is to assess the safety, tolerability, and pharmacokinetics (PK) of oral JNT-517 in adolescents (12 to less than 18 years of age) with PKU.
- Trial name
- NCT06637514
- Testing
- JNT-517 Tablet
- Where
- 7 sites in United States, Australia
- Volunteers
- 14 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Multiple Myeloma
IV Busulfan Plus Bortezomib Conditioning Regimen for Second Autologous Stem Cell Transplant in Multiple Myeloma Patients
Study for the outcome and safety of individualized busulfan dosing with bortezomib for patients preparing for a second stem cell transplant to treat multiple myeloma.
- Trial name
- NCT01009840
- Testing
- IV busulfan, bortezomib, Autologous Hematopoietic Stem Cell Transplant (HSCT)
- Where
- 13 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autistic Disorder
Study of Aripiprazole in the Treatment of Children and Adolescents With Autistic Disorder (AD).
This study will compare the effectiveness (how well the drug works) of aripiprazole, flexibly dosed with a placebo, in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
- Trial name
- NCT00332241
- Testing
- Aripiprazole
- Where
- 9 sites in United States
- Volunteers
- 98 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Bipolar Disorder
A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode
Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode
- Trial name
- NCT00277212
- Testing
- Lamotrigine + Aripiprazole
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 1,169 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteers
How [14C]-JNT-517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants
The purpose of this study is to determine the absorption, metabolism and excretion of [14C]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a…
- Trial name
- NCT07573449
- Testing
- [14C]-JNT-517
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
ADHD, Anxiety
P3b Short-term Study of CTN in Patients With ADHD and Comorbid Anxiety
Primary: To evaluate the efficacy of CTN in adults ages with ADHD and comorbid anxiety (AISRS) Key Secondary: To assess the efficacy of CTN in adults ages with ADHD and comorbid anxiety
- Conditions
- ADHD, Anxiety, Generalized Anxiety, Social Anxiety Disorder
- Trial name
- NCT06973577
- Testing
- Centanafadine
- Where
- 47 sites in United States, Puerto Rico
- Volunteers
- 315 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
ADHD
A Trial to Assess How Centanafadine Interacts With Stimulants in the Body
This study will look at how centanafadine works when taken together with stimulant medicines in healthy adults, and whether combining them affects how the body responds.
- Trial name
- NCT07314333
- Testing
- Centanafadine, Methylphenidate, Lisdexamfetamine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immunoglobulin A Nephropathy
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN
- Trial name
- NCT05248659
- Testing
- Sibeprenlimab 400 mg s.c. Q4weeks
- Where
- 158 sites in United States, Argentina and 29 more
- Volunteers
- 600 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Phenylketonuria (PKU)
A Long-Term Study of JNT-517 in Participants With Phenylketonuria
The goal of this Phase 3, open-label study is to evaluate the long-term safety of JNT-517 in pediatric and adult participants with Phenylketonuria (PKU) after completion of either Study JNT517-101 (NCT05781399) or JNT517-201…
- Trial name
- NCT06628128
- Testing
- JNT-517
- Where
- 12 sites in United States, Australia
- Volunteers
- 240 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
This is a phase 1, randomized, placebo-controlled, double-blind, single ascending dose study of IV VIS649 in healthy subjects. VIS649 is a monoclonal immunoglobulin G2 (IgG2) antibody targeting the B-cell growth factor APRILL.
- Conditions
- Immunoglobulin A Nephropathy, IgAN - IgA Nephropathy, IgA Nephropathy
- Trial name
- NCT03719443
- Testing
- VIS649
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy Volunteer
A Phase 1 Study Comparing AVP-786 With AVP-923
To compare pharmacokinetics (PK) of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) to AVP-923 (dextromethorphan hydrobromide [DM]/Q) at steady state.
- Trial name
- NCT02336347
- Testing
- AVP-786, AVP-923
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
- Trial name
- DDI (NCT02402595)
- Testing
- AVP-923, AVP-786, Itraconazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [DM]/quinidine sulfate [Q]) in healthy volunteers.
- Trial name
- NCT02174835
- Testing
- AVP-786, AVP-923
- Where
- Australia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Observational Study in Patients With Autosomal Dominant Polycystic Kidney Disease
To collect characteristics of patients with ADPKD across a broad population, over time to better understand disease progression (signs, symptoms and outcomes).
- Trial name
- OVERTURE (NCT01430494)
- Where
- 266 sites in United States, Argentina and 18 more
- Volunteers
- 3,409 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers
To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.
- Trial name
- NCT01787747
- Testing
- AVP-786 Dose 1, AVP-786 Dose 2, AVP-786 Dose 1/Q Dose 1
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.