Clinical trials: sponsored by Takeda
Solid Neoplasms
A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone…
- Trial name
- iintune-1 (NCT04420884)
- Testing
- Dazostinag, Pembrolizumab, Platinum
- Where
- 62 sites in United States, Austria and 9 more
- Volunteers
- 248 people
- Sponsor
- Takeda
Celiac Disease
Dose-Ranging Study of the Efficacy and Safety of TAK-101 for Prevention of Gluten-Specific T Cell Activation in Participants With Celiac Disease on a Gluten-Free Diet
The main aim of the study is to assess if TAK-101 can reduce gluten related symptoms and immune activation in adult participants with celiac disease (CeD) on a gluten-free diet (GFD).
- Trial name
- NCT04530123
- Testing
- TAK-101, Gluten
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 102 people
- Sponsor
- Takeda
Primary Immunodeficiency Diseases (PID)
A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases
The main aim of this study is to evaluate the PK, safety, tolerability and immunogenicity of subcutaneous (SC) administration of TAK-881 in adult and pediatric participants with PIDD and compare them to HYQVIA in participants 16…
- Trial name
- NCT05755035
- Testing
- TAK-881, HYQVIA
- Where
- 32 sites in United States, Czechia and 6 more
- Volunteers
- 65 people
- Sponsor
- Takeda
Leukemia
A Study of GDX012 in Adults With Relapsed or Refractory Acute Myeloid Leukemia
GDX012 is a novel cell therapy developed for the treatment of certain types of cancer, including Acute Myeloid Leukemia (AML). The main aims of the study are to learn how safe GDX012 is, how treatment with GDX012 is tolerated and…
- Trial name
- NCT05886491
- Testing
- GDX012, Chemotherapy Agents
- Where
- 11 sites in United States, Japan
- Volunteers
- 16 people
- Sponsor
- Takeda
Squamous Cell Cancer of Head and Neck (SCCHN), Non-small Cell Lung Cancer (NSCLC)
A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer
The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer.
- Conditions
- Squamous Cell Cancer of Head and Neck (SCCHN), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer
- Trial name
- NCT04844073
- Testing
- TAK-186
- Where
- 27 sites in United States, Australia and 2 more
- Volunteers
- 95 people
- Sponsor
- Takeda
Multiple System Atrophy
A Study of TAK-341 in Treatment of Multiple System Atrophy
The main aim is to see how TAK-341 works after 52 weeks in participants with multiple system atrophy as measured by the Unified Multiple System Atrophy Rating Scale Part I (UMSARS).
- Trial name
- NCT05526391
- Testing
- TAK-341
- Where
- 41 sites in United States, Austria and 8 more
- Volunteers
- 158 people
- Sponsor
- Takeda
Acute Myeloid Leukemia (AML)
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy.
- Trial name
- PEVENAZA (NCT04266795)
- Testing
- Pevonedistat, Venetoclax, Azacitidine
- Where
- 57 sites in United States, Canada and 3 more
- Volunteers
- 164 people
- Sponsor
- Takeda
Healthy Volunteers
A Study of Soticlestat in Healthy Adult Nondependent Recreational Drug Users With Central Nervous System (CNS) Depressant Experience
The main aim is to evaluate the relative abuse potential of soticlestat in healthy adults who has used central nervous system (CNS) depressants for recreational nontherapeutic reasons.
- Trial name
- NCT05602818
- Testing
- Soticlestat 300 mg, Soticlestat 600 mg, Soticlestat 900 mg
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteer
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).
- Trial name
- NCT04461483
- Testing
- TAK-935
- Where
- Japan
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Takeda
Epilepsy
TAK-935 Multiple Rising Dose Study in Healthy Participants
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of multiple rising doses of TAK-935 in healthy participants.
- Trial name
- NCT02539134
- Testing
- TAK-935
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Hepatic Impairment, Healthy Volunteers
A Study of Soticlestat in Adults With Liver Failure Compared to Those With Normal Liver Function
The main aim is to check the effect of a single dose of soticlestat in adults with moderate or mild liver failure compared to healthy adults with normal liver function. Participants will check into the study clinic for 8 days.
- Trial name
- NCT05098054
- Testing
- Soticlestat
- Where
- 6 sites in United States, Hungary
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
The purpose of this study is to characterize the safety and tolerability profile of TAK-935 in healthy participants when administered as a single dose of oral solution at escalating dose levels.
- Trial name
- NCT02201056
- Testing
- TAK-935
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Takeda
Epilepsy, Molecular Mechanisms of Pharmalogical Action, Protective Agents
A Phase 1 Positron Emission Tomography Study to Measure Cholesterol 24S-Hydroxylase Target Occupancy of TAK-935
The purpose of this study is to determine the brain cholesterol 24S-hydroxylase (CH24H) enzyme occupancy of TAK-935 after single oral dose in healthy participants using the positron emission tomography (PET) ligand [18F]MNI-792…
- Trial name
- NCT02497235
- Testing
- TAK-935, [18F]MNI-792 (tracer)
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
Study to Assess Absolute Bioavailability of TAK-935 (OV935) and to Characterize Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]TAK-935 (OV935) in Healthy Male Participants
The purpose of this study is to determine absolute bioavailability (ABA) of TAK-935 (F) following a single microdose intravenous (IV) administration of 50 microgram (μg) (approximately 1 microcurie [μCi]) [14C]TAK-935 and a…
- Trial name
- NCT04992442
- Testing
- TAK-935 Oral Tablet, [14C]TAK-935 IV Infusion, [14C]TAK-935 Oral Solution
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Takeda
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Healthy Volunteers
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in…
- Trial name
- NCT02906813
- Testing
- TAK-935 Tablets, TAK-935 Oral Solution
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Takeda
Developmental and/or Epileptic Encephalopathies
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to characterize the multiple-dose safety and tolerability profile of TAK-935 in adult participants with developmental and/or epileptic encephalopathies.
- Trial name
- NCT03166215
- Testing
- TAK-935
- Where
- 11 sites in United States
- Volunteers
- 18 people
- Sponsor
- Takeda
Healthy Volunteers
A Study of Soticlestat and Rifampin in Healthy Adults
The main aim of this study is to check how rifampin affects the way soticlestat is processed by the body. Participants will be required to stay at the study clinic for 18 consecutive days.
- Trial name
- NCT05098041
- Testing
- Soticlestat, Rifampin
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Takeda
15q Duplication Syndrome, CDKL5 Deficiency Disease
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
- Trial name
- NCT03694275
- Testing
- Soticlestat
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Takeda
Healthy Volunteers
A Study of Soticlestat Tablets in Healthy Adults
The main aim is to see how soticlestat tablets of different strengths work and to compare how it works alone in contrast to administration along with food. In the study will be 2 groups of participants (part A and part B).
- Trial name
- NCT05284760
- Testing
- Soticlestat
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Takeda