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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

ASP3325 tablets A will be orally administered with 150 mL of water in fasting condition on non-dialysis day in Day 1

ASP3325 tablets B will be orally administered t.i.d. 30 minutes before each meal for 2 weeks

ASP3325 tablets B will be orally administered t.i.d. 30 minutes just after each meal for 2 weeks

3325-cl-0003-clrrs-02-disc01-en-final-02.pdf

3325-cl-0003-clls-disc01_180822.pdf

The objective of this study is to assess PK, safety and tolerability of a single oral dose of ASP3325 and to assess PD, PK and safety of repeated oral doses of ASP3325 administered t.i.d. before or just after each meal

Single and multiple dosing study in hemodialysis patients with hyperphosphatemia in Japan

[Part 1]
This part is an open-label, uncontrolled study to evaluate PK and safety with single dosing of ASP3325 in hemodialysis patients. After washout period of therapeutic medication for hyperphosphatemia, six subjects will receive single oral administration of ASP3325 (Tablet A) on a non-dialysis day (Day 1). 

[Part 2]
This part is a 2-arm, open-label, uncontrolled study to evaluate PD, PK and safety with dosing ASP3325 Tablet B t.i.d. before or just after each meal. 
Eligible subjects at screening will be entered into the washout period for stopping their phosphate-binding treatment. 20 subjects with serum inorganic phosphorus (Pi) level between ≥6.0 and <10.0 mg/dL during the washout period (washout period week 1 or washout period week 2) will be randomized to each treatment group and ASP3325 will be administered for 2 weeks until Day 14.

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Link to results on the Astellas Clinical Study Results website

Site: 5

Site: 2

Site: 4

Site: 3

Site: 1

A Phase 1, Single and Multiple Dosing Study to Evaluate Pharmacokinetics and Pharmacodynamics of ASP3325 in Patients with Chronic Kidney Disease and Hyperphosphatemia Undergoing Hemodialysis

Vital signs include body temperature, blood pressure and pulse rate)

Clinical laboratory tests include hematology and biochemistry

tmax = time to reach maximum plasma concentration

AUClast: Area under the Curve of plasma concentration during observation period in each observational day

AUCinf: Area under the Curve of plasma concentration

t1/2 = apparent terminal elimination half-life

Serum Pi: serum phosphate concentration before dialysis

Corrected value of Calcium (Ca) (mg/dL) = Observed value of Ca (mg/dL) + [4-albumin (g/dL)