Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
- Lead sponsor (exact) Astellas Pharma Global Development, Inc.
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Healthy Volunteer
A Study to Learn How ASP3082 is Processed in Healthy Men
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers.
- Trial name
- NCT07773129
- Testing
- 14C-labeled ASP3082
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes.
- Trial name
- NCT07783282
- Testing
- fezolinetant, enzalutamide, apalutamide
- Where
- Bulgaria
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers, Sjögren's Syndrome
A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome
Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth.
- Trial name
- NCT06544642
- Testing
- ASP5502
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteer
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty.
- Trial name
- NCT07395024
- Testing
- Setidegrasib, Fluconazole, Carbamazepine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers, Renal Impairment
A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05495581
- Testing
- pudexacianinium chloride
- Where
- 4 sites in United States, Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Participants
A Study to Find a Suitable Dose of ASP8731 and Check for Medical Problems at Each Dose in Healthy Adults
ASP8731 is a potential new treatment for people with sickle cell disease. Before ASP8731 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body.
- Trial name
- NCT05167526
- Testing
- ASP8731
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects
A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of…
- Trial name
- NCT04096157
- Testing
- Isavuconazonium sulfate IV, Isavuconazonium sulfate capsules
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Impairment, Healthy
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
- Trial name
- NCT02571816
- Testing
- ASP2215
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Renal Impaired, Gilteritinib
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal…
- Conditions
- Renal Impaired, Gilteritinib, Normal Renal Function, Pharmacokinetics of ASP2215
- Trial name
- NCT04699877
- Testing
- Gilteritinib
- Where
- 4 sites in United States, Bulgaria
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects
The purpose of this study is to assess the potential for pharmacokinetic (PK) and pharmacodynamics (PD) interactions between ASP8062 and alcohol.
- Trial name
- NCT04003402
- Testing
- ASP8062, Alcohol
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Adult Subjects
A Study to Assess the Relative Bioavailability of Roxadustat Following a Single Dose of Pediatric Azo Dye-free Tablet Formulation and Pediatric Azo Dye-free Mini-tablet Formulation Compared to a Single Dose of Azo Dye-containing Tablet Formulation in Healthy Adult Subjects
The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new…
- Trial name
- NCT03960489
- Testing
- Roxadustat
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect
The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants.
- Trial name
- NCT04077879
- Testing
- ASP1617
- Where
- United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
A Study to Learn How [14C]ASP0367 is Processed by the Body in Healthy Men
ASP0367 is a potential new treatment for people with Duchenne Muscular Dystrophy and Mitochondrial Myopathies. Before ASP0367 is available as a treatment, the researchers need to understand how it is processed by and acts upon…
- Trial name
- NCT05217901
- Testing
- 14C-labeled ASP0367
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Impairment, Healthy Volunteers
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.
- Trial name
- NCT04942964
- Testing
- Bocidelpar
- Where
- 3 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Renal Impairment, Healthy Volunteers
A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People
This study is for adults whose kidneys do not work well (renal impairment) and adults whose kidneys work normally. This study will provide more information on a potential new treatment, called ASP0367.
- Trial name
- NCT05117294
- Testing
- Bocidelpar
- Where
- 4 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions.
- Trial name
- NCT04277624
- Testing
- fezolinetant - test formulation, fezolinetant - reference formulation
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Subjects
A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants
The purpose of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants.
- Trial name
- NCT04641260
- Testing
- Fezolinetant
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers, Renal Impairment
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with varying levels of renal impairment (mild, moderate and severe)…
- Trial name
- NCT04476849
- Testing
- fezolinetant
- Where
- 7 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Dialysis, Healthy Subjects
An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients
The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers…
- Conditions
- Dialysis, Healthy Subjects, Cytomegalovirus Infection
- Trial name
- NCT02103426
- Testing
- ASP0113
- Where
- 4 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Hepatic Impairment, Healthy Volunteers
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of fezolinetant and ES259564 (fezolinetant metabolite) in female participants with mild and moderate hepatic impairment compared to healthy…
- Trial name
- NCT04482270
- Testing
- fezolinetant
- Where
- 4 sites in United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.