Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Peanut Allergy
A Study to Evaluate Safety, Tolerability and Immune Response in Adolescents Allergic to Peanut After Receiving Intradermal Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal (ID) injection in adolescent participants with peanut allergy.
- Trial name
- NCT03755713
- Testing
- ASP0892
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Rheumatoid Arthritis
A Study to Evaluate the Pharmacokinetics of ASP1707 and Methotrexate in Patients With Rheumatoid Arthritis
The primary purpose of the study is to evaluate the effect of ASP1707 twice daily on the pharmacokinetics of once weekly oral methotrexate (MTX).
- Trial name
- NCT02867306
- Testing
- ASP1707, methotrexate (MTX)
- Where
- Moldova
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Peanut Allergy
A Study to Evaluate Safety, Tolerability and Immune Response in Adults Allergic to Peanut After Receiving Intradermal or Intramuscular Administration of ASP0892 (ARA-LAMP-vax), a Single Multivalent Peanut (Ara h1, h2, h3) Lysosomal Associated Membrane Protein DNA Plasmid Vaccine
The purpose of this study is to evaluate the safety and tolerability of ASP0892 after intradermal or intramuscular injection in adults with peanut allergy.
- Trial name
- NCT02851277
- Testing
- ASP0892 Intradermal, ASP0892 Intramuscular
- Where
- 8 sites in United States
- Volunteers
- 31 people
- 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.
Invasive Fungal Infection
Registry of Patients Treated With Systemic Mold-Active Triazoles
The purpose of this study is to describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI).
- Trial name
- NCT03066011
- Testing
- Isavuconazonium sulfate, Voriconazole, Posaconazole
- Where
- 56 sites in United States
- Volunteers
- 2,015 people
- 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.
Arthritis, Rheumatoid
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
The purpose of this study is to evaluate the long-term safety and efficacy of ASP015K in subjects with Rheumatoid Arthritis (RA) who have completed a preceding Phase 2 ASP015K RA study.
- Trial name
- NCT01711814
- Testing
- peficitinib
- Where
- 51 sites in United States, Belgium and 6 more
- Volunteers
- 611 people
- 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.
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.
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.
Healthy Subjects
A Study in Healthy Adult Volunteers to Assess the Safety and Pharmacokinetics of an Investigational Imaging Product
The objective of this study is to assess the safety and tolerability of ASP5354 administered intravenously as a single dose to healthy subjects.
- Trial name
- NCT03698305
- Testing
- ASP5354
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
A Study to Assess ASP2713 in Healthy Subjects
The purpose of this study is to evaluate safety and tolerability of ASP2713 in healthy participants. The study will also evaluate the pharmacokinetics and pharmacodynamics of ASP2713.
- Trial name
- NCT04017208
- Testing
- ASP2713
- Volunteers
- healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteer
A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects
The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib…
- Trial name
- NCT03964038
- Testing
- gilteritinib, gilteritinib mini tablet
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2).
- Trial name
- NCT03682484
- Testing
- MA-0211
- Where
- United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission…
- Trial name
- NCT03070093
- Testing
- gilteritinib
- Where
- 39 sites in United States, Canada and 1 more
- Sponsor
- Astellas Pharma Global Development, Inc.
Overactive Bladder (OAB)
A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)
The purpose of this study was to assess tolerability of mirabegron compared to tolterodine ER in the treatment of participants with symptoms of Overactive Bladder (OAB) as well as the impact of treatment on micturition frequency…
- Trial name
- PREFER (NCT02138747)
- Testing
- Mirabegron, Tolterodine ER
- Where
- 30 sites in United States, Canada
- Volunteers
- 376 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Locally Advanced or Metastatic Urothelial Carcinoma (UC)
An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
The primary purpose of this expanded access program is to evaluate safety and tolerability of enfortumab vedotin (EV) in participants in the United States with locally advanced or metastatic urothelial carcinoma (UC) who have…
- Trial name
- NCT04136808
- Testing
- enfortumab vedotin (EV)
- Where
- 15 sites in United States
- Sponsor
- Astellas Pharma Global Development, Inc.