Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Prostate Cancer, Castration-resistant Prostate Cancer
A Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-resistant Prostate Cancer and Men With Metastatic Prostate Cancer
The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and…
- Conditions
- Prostate Cancer, Castration-resistant Prostate Cancer, Metastatic Prostate Cancer
- Trial name
- ASPIRE-PCa (NCT02066961)
- Where
- 93 sites in Algeria, Argentina and 25 more
- Volunteers
- 1,533 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Painful Diabetic Peripheral Neuropathy (PDPN)
Study to Assess Analgesic Efficacy and Safety of ASP3662 in Subjects With Painful Diabetic Peripheral Neuropathy
The purpose of this study is to assess analgesic efficacy of ASP3662 relative to placebo in subjects with painful diabetic peripheral neuropathy (PDPN) as well as assess the safety and tolerability of ASP3662 relative to placebo.
- Trial name
- NCT02372578
- Testing
- ASP3662, pregabalin
- Where
- 37 sites in United States
- Volunteers
- 115 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in…
- Trial name
- NCT03409081
- Testing
- gilteritinib
- Where
- 6 sites in Australia, Italy and 1 more
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Castration Resistant Prostate Cancer
A Study of Enzalutamide Re-treatment in Metastatic Castration-resistant Prostate Cancer After Docetaxel and/or Cabazitaxel Treatment
The purpose of the study was to understand if there is benefit in treatment with a medicine called enzalutamide in the re-treatment setting.
- Trial name
- NCT02441517
- Testing
- Enzalutamide
- Where
- 5 sites in United States
- Volunteers
- 4 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Epidermal Growth Factor Receptor (EGFR) Mutations, Solid Tumors
A Study to Investigate the Absorption, Metabolism and Excretion of [14C]ASP8273 in Subjects With Solid Tumors
This is a study to investigate the absorption, metabolism and excretion of [14C] labeled ASP8273 in subjects with solid tumors harboring EGFR mutations (per local testing). This study consists of two parts (A and B).
- Trial name
- NCT02674555
- Testing
- radio-labeled naquotinib, naquotinib
- Sponsor
- Astellas Pharma Global Development, Inc.
Subjects With NSCLC With an EGFR Activating Mutation
A Study for Subjects Who Are Participating in an Astellas-sponsored ASP8273 Study
The purpose of the study is to evaluate long-term safety and tolerability of continuous treatment with ASP8273 in subjects who are participating in an Astellas-sponsored ASP8273 study which has completed, at a minimum, the…
- Trial name
- NCT03042013
- Testing
- ASP8273
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Castration-Resistant Prostate Cancer
Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.
- Trial name
- NCT01606982
- Testing
- MDV3100
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of ASP3662, Displacement of Radiotracer
A Positron Emission Tomography Occupancy Study Using Ligand [11C]AS2471907 and Following Oral Dosing of ASP3662
The purpose of this study is to evaluate a novel PET tracer ([11C]AS2471907), and to use [11C]AS2471907 to assess the level and time-course of enzyme occupancy in the human brain prior to and following single oral dose…
- Conditions
- Pharmacokinetics of ASP3662, Displacement of Radiotracer, Healthy Volunteers
- Trial name
- NCT02194491
- Testing
- [11C]AS2471907, Positron Emission Tomography (PET), ASP3662
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Coronary Artery Disease (CAD)
A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with…
- Trial name
- EXERRT (NCT01618669)
- Testing
- Regadenoson, Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)
- Where
- 69 sites in United States, Argentina and 2 more
- Volunteers
- 1,147 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Candidiasis
Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.
- Trial name
- MAGIC-2 (NCT00815516)
- Testing
- micafungin, amphotericin B deoxycholate
- Where
- 17 sites in United States, Brazil and 10 more
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of ASP015K, Food Effect
A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K
The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release…
- Conditions
- Pharmacokinetics of ASP015K, Food Effect, Healthy Volunteers
- Trial name
- NCT01686217
- Testing
- ASP015K ER, ASP015K IR
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Effect of Renal Impairment on the Pharmacokinetics of Isavuconazole.
This is a 2-part, open-label study, designed to evaluate the effect of renal disease on the pharmacokinetics of BAL4815 (active isavuconazole moiety) relative to the pharmacokinetics in healthy subjects with normal renal function.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Renal Impaired
- Trial name
- NCT01555866
- Testing
- isavuconazole
- Where
- 3 sites in United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Digoxin
Drug Interaction Study of Isavuconazole and Digoxin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of digoxin in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Digoxin, Healthy Volunteers
- Trial name
- NCT01582412
- Testing
- Isavuconazole, digoxin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ketoconazole
Drug Interaction Study of the Effect of Ketoconazole at Steady State on the Pharmacokinetics of a Single Dose of Isavuconazole in Healthy Adult Subjects
The purpose of this study is to assess the effect of ketoconazole at steady state on the pharmacokinetics of a single dose of isavuconazole in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ketoconazole, Healthy Adult Volunteers
- Trial name
- NCT01657838
- Testing
- Isavuconazole, Ketoconazole
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion
Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion, Healthy Volunteers
- Trial name
- NCT01635972
- Testing
- Isavuconazole, bupropion hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Healthy Volunteers
Study of the Pharmacokinetics of Isavuconazole in Healthy Non-Elderly and Elderly Male and Female Subjects
The purpose of this study is to evaluate the pharmacokinetics of isavuconazole in healthy non-elderly and elderly male and female subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Healthy Volunteers, Safety and Tolerability in Elderly
- Trial name
- NCT01657890
- Testing
- isavuconazole
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Dextromethorphan
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Dextromethorphan in Healthy Adult Subjects
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of dextromethorphan in healthy adult subjects.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Dextromethorphan, Healthy Adult Volunteers
- Trial name
- NCT01651325
- Testing
- Isavuconazole, dextromethorphan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Lopinavir/Ritonavir
Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole
The purpose of this two part study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the effect of multiple doses of lopinavir/ritonavir on the…
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Lopinavir/Ritonavir, Healthy Volunteers
- Trial name
- NCT01660477
- Testing
- Isavuconazole, Lopinavir/ritonavir
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Atorvastatin
Drug Interaction Study of Multiple Doses of Isavuconazole and Single Dose of Atorvastatin
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of atorvastatin.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Atorvastatin, Healthy Volunteers
- Trial name
- NCT01635946
- Testing
- Isavuconazole, atorvastatin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Rheumatoid Arthritis, Pharmacokinetics of ASP2409
A Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ASP2409 Following a Single Intravenous Dose in Patients With Rheumatoid Arthritis on Methotrexate
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of single, ascending, intravenous (IV) doses of ASP2409 in patients with Rheumatoid Arthritis (RA) on methotrexate (MTX) and to evaluate…
- Trial name
- NCT02171143
- Testing
- ASP2409
- Where
- 10 sites in United States
- Volunteers
- 58 people
- Sponsor
- Astellas Pharma Global Development, Inc.