Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Hematological Malignancy
A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients
The purpose of the study is to evaluate the pharmacokinetics (PK), safety and tolerability of multiple doses of intravenous (IV) and oral isavuconazonium sulfate administered daily in pediatric patients.
- Trial name
- NCT03241550
- Testing
- isavuconazonium sulfate - intravenous, isavuconazonium sulfate - oral
- Where
- 16 sites in United States
- Volunteers
- 49 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Candidiasis, Systemic, Candida Meningitis
Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis
The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis.
- Trial name
- NCT03421002
- Testing
- Micafungin
- Where
- 2 sites in Italy
- Volunteers
- 35 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Renal Cell Carcinoma
A Study of AGS-16C3F vs. Axitinib in Metastatic Renal Cell Carcinoma
The purpose of this study was to evaluate the progression free survival (PFS), based on investigator radiologic review, of AGS-16C3F compared to axitinib in subjects with metastatic renal cell carcinoma.
- Trial name
- NCT02639182
- Testing
- AGS-16C3F, Axitinib
- Where
- 26 sites in United States, Canada
- Volunteers
- 133 people
- Sponsor
- Astellas Pharma Global Development, Inc.
CLDN18.2-positive Gastric Adenocarcinoma, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction
Safety and Activity of IMAB362 in Combination With Zoledronic Acid and Interleukin-2 in CLDN18.2-positive Gastric Cancer
The purpose of the trial is to assess the immunological effects and their kinetics, the safety and activity of IMAB362 plus Zoledronic acid with/without low to intermediate doses of Interleukin-2 in subjects with advanced…
- Conditions
- CLDN18.2-positive Gastric Adenocarcinoma, CLDN18.2-positive Adenocarcinoma of the Gastroesophageal Junction, CLDN18.2-positive Adenocarcinoma of Esophagus
- Trial name
- PILOT (NCT01671774)
- Testing
- IMAB362, Zoledronic acid, Interleukin-2 (1 million IU)
- Where
- 9 sites in Germany, Latvia
- Volunteers
- 29 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Chronic Obstructive Pulmonary Disease (COPD)
A Study to Assess the Effect of CK-2127107 on Physical Function in Subjects With Chronic Obstructive Pulmonary Disease
The purpose of this study was to assess the effect of CK-2127107 relative to placebo on cycle ergometer exercise tolerance, assessed as change from period baseline in constant work rate (CWR) endurance time, utilizing a…
- Trial name
- NCT02662582
- Testing
- Reldesemtiv
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-Small-Cell Lung Cancer (NSCLC), Epidermal Growth Factor Receptor Mutations
A Dose Escalation Study of ASP8273 in Subjects With Non-Small-Cell Lung Cancer (NSCLC) Who Have Epidermal Growth Factor Receptor (EGFR) Mutations
The purpose of this study is to assess the safety and tolerability of ASP8273 and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
- Trial name
- NCT02113813
- Testing
- naquotinib, midazolam
- Where
- 12 sites in United States
- Volunteers
- 133 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and…
- Trial name
- Dolphin (NCT04641975)
- Testing
- Mirabegron
- Where
- 15 sites in Belgium, France and 8 more
- Volunteers
- 26 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Incurable Platinum Refractory Germ Cell Tumors, Tumors
A Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors
The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in…
- Trial name
- NCT03760081
- Testing
- ASP1650
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Benign Prostatic Hyperplasia, Overactive Bladder
A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)
The purpose of the study was to assess the efficacy, safety, and tolerability of mirabegron versus placebo in men with overactive bladder (OAB) symptoms while taking tamsulosin hydrochloride for lower urinary tract symptoms…
- Trial name
- PLUS (NCT02757768)
- Testing
- Mirabegron, Tamsulosin Hydrochloride
- Where
- 79 sites in United States, Canada and 7 more
- Volunteers
- 715 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Schizophrenia
A Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication
The purpose of this study was to evaluate the efficacy of ASP4345 on cognitive impairment compared to placebo using change from baseline in MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score (excluding…
- Trial name
- NCT03557931
- Testing
- ASP4345, risperidone, quetiapine
- Where
- 27 sites in United States
- Volunteers
- 233 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors, Pharmacokinetics of 14C-OSI-906
A Study to Look at How a Single Oral Dose of 14C-OSI-906 is Absorbed, Broken Down and Eliminated in the Body
The purpose of this study is to evaluate the pharmacokinetics, in particular the routes of excretion and extent of metabolism of OSI-906 after a single oral dose of 14C-labeled OSI-906.
- Trial name
- NCT01529684
- Testing
- radio-labeled OSI-906, OSI-906
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of ASP9853, Non-hematologic Malignancies
A Phase 1, Dose Escalation Study to Assess the Safety and Tolerability of ASP9853 With Either Docetaxel or Paclitaxel in Patients With Advanced Non-hematologic Malignancies
The purpose of this study is to determine the safety and tolerability and pharmacokinetics of ASP9853 combined with docetaxel or with paclitaxel in subjects with advanced non-hematologic malignancies.
- Trial name
- NCT01705483
- Testing
- ASP9853, Docetaxel, Paclitaxel
- Where
- 4 sites in United States
- Volunteers
- 21 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Chronic Kidney Disease
Incidence and Clinical Burden of Erythropoietin Hyporesponsiveness - a Retrospective Database Analysis
This study consists of two phases. The purpose of phase 1 is to identify incidence and patterns of erythropoiesis-stimulating agent (ESA) hyporesponsiveness and its associated factors in ESA treated patients.
- Trial name
- NCT05530291
- Testing
- Non-interventional
- Where
- Germany
- Volunteers
- 85,259 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Opioid Use Disorder
A Study to Assess the Safety and Efficacy of ASP8062 as an Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder
The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone.
- Trial name
- NCT05062577
- Testing
- ASP8062, buprenorphine/naloxone
- Sponsor
- Astellas Pharma Global Development, Inc.
Hot Flashes
A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause
This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life.
- Trial name
- Skylight 4 (NCT04003389)
- Testing
- fezolinetant
- Where
- 182 sites in United States, Canada and 6 more
- Volunteers
- 1,831 people
- 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.
Advanced Solid Tumors, Pharmacokinetics of 14C-labeled Gilteritinib
Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled…
- Trial name
- NCT02456883
- Testing
- gilteritinib, 14C-labeled gilteritinib
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML)
Treatment Patterns and Key Healthcare Resource Use in Acute Myeloid Leukemia (AML) With or Without FMS-like Tyrosine Kinase-3 (FLT3) Mutation Study Based on Retrospective Chart Review
The purpose of this study is to retrospectively evaluate the treatment patterns and AML-related key healthcare resource use among AML patients, stratified by FLT3 mutation status, intensive chemotherapy (IC) eligibility, and…
- Trial name
- NCT03047083
- Testing
- Treatment patterns among AML patients, AML-related healthcare resources
- Where
- United States
- Volunteers
- 1,027 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 - 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.
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.