Clinical trials: sponsored by 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.
Hot Flashes
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2
This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
- Trial name
- Skylight 2 (NCT04003142)
- Testing
- Fezolinetant
- Where
- 93 sites in United States, Canada and 5 more
- Volunteers
- 501 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hot Flashes
A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause
This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
- Trial name
- Skylight 1 (NCT04003155)
- Testing
- fezolinetant
- Where
- 96 sites in United States, Canada and 5 more
- Volunteers
- 527 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Relapsed Lymphoid Malignancy, Refractory Lymphoid Malignancy
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Refractory or Relapsed Lymphoid Malignancies
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of AGS67E both without and with myeloid growth factor (GF) in subjects with refractory or relapsed lymphoid malignancies.
- Trial name
- NCT02175433
- Testing
- AGS67E
- Where
- 5 sites in United States, Canada
- Volunteers
- 71 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Study of ASP1951 in Subjects With Advanced Solid Tumors
The primary purpose of this study is to evaluate the tolerability and safety profile of ASP1951 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or…
- Trial name
- NCT03799003
- Testing
- ASP1951, pembrolizumab
- Where
- 32 sites in United States, Canada and 2 more
- Volunteers
- 119 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Doses of AGS67E Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety and tolerability of AGS67E in subjects with acute myeloid leukemia (AML) and determine a safe dose for future development.
- Trial name
- NCT02610062
- Testing
- AGS67E
- Where
- 4 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Study of ASP1948, Targeting an Immune Modulatory Receptor as a Single Agent and in Combination With a PD-l Inhibitor (Nivolumab or Pembrolizumab) in Subjects With Advanced Solid Tumors
The purpose of this study is to evaluate the tolerability and safety profile of ASP1948 when administered as a single agent and in combination with nivolumab or pembrolizumab in participants with locally advanced (unresectable)…
- Trial name
- NCT03565445
- Testing
- ASP1948, nivolumab, pembrolizumab
- Where
- 42 sites in United States, Canada and 7 more
- Volunteers
- 190 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Urothelial Cancer
ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer
The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for…
- Trial name
- NCT01963052
- Testing
- AGS15E
- Where
- 11 sites in United States, Canada
- Volunteers
- 93 people
- 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.
Rheumatoid Arthritis (RA)
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple ascending intravenous doses of ASP5094 in male and female subjects with rheumatoid arthritis (RA) on methotrexate (MTX).
- Trial name
- NCT02698657
- Testing
- ASP5094
- Where
- 13 sites in United States, Poland
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Schizophrenia
A Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of ASP6981 in Subjects With Schizophrenia
The primary purpose is to evaluate the safety and tolerability of ASP6981 in participants with schizophrenia. Also primary purpose is to evaluate the pharmacodynamics of ASP6981 in participants with schizophrenia as measured by…
- Trial name
- NCT03356639
- Testing
- ASP6981
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Schizophrenia
A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP4345 in Patients With Schizophrenia
The purpose of this study is to evaluate the safety and tolerability of multiple ascending oral doses of ASP4345 in patients with schizophrenia.
- Trial name
- NCT02720263
- Testing
- ASP4345
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Mobility Limitation
A Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility
The purpose of this study is to investigate the effect of CK-2127107 versus placebo on skeletal muscle fatigue assessed as change from baseline versus 14 days of treatment in sum of peak torque during isokinetic knee extensions.
- Trial name
- NCT03065959
- Testing
- reldesemtiv
- Where
- 5 sites in United States
- Volunteers
- 42 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Lymphoma, Refractory Solid Tumors
A Dose Escalation and Expansion Study of ASP4132 to Subjects With Advanced Refractory Tumors and Lymphoma
The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to determine the maximum tolerated dose and recommended phase 2 dose of ASP4132.
- Conditions
- Lymphoma, Refractory Solid Tumors, Advanced Cancer
- Trial name
- NCT02383368
- Testing
- ASP4132
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Fibromyalgia
A Study to Assess the Analgesic Efficacy and Safety of ASP0819 in Patients With Fibromyalgia
This study assessed analgesic efficacy of ASP0819 relative to placebo as well as the safety and tolerability. This study assessed treatment differences in physical function as well as the improvements in overall subject status…
- Trial name
- NCT03056690
- Testing
- ASP0819
- Where
- 24 sites in United States
- Volunteers
- 186 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Vasomotor Symptoms
A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause
This study is for women in menopause who have moderate to severe hot flashes. It is for women who are unable to use hormone replacement therapy (HRT). Menopause, a normal part of life, is the time after a woman's last period.
- Trial name
- Daylight (NCT05033886)
- Testing
- fezolinetant
- Where
- 69 sites in Belgium, Canada and 14 more
- Volunteers
- 453 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Cytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant.
- Trial name
- HELIOS (NCT01877655)
- Testing
- ASP0113
- Where
- 83 sites in United States, Australia and 9 more
- Volunteers
- 514 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Kidney Transplantation Cytomegalovirus (CMV) Negative Recipients
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor.
- Trial name
- NCT01974206
- Testing
- ASP0113
- Where
- 53 sites in United States, Australia and 4 more
- Volunteers
- 150 people
- 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.
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.