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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.  Further details on Astellas’ data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.

The ureter is the tube that carries urine from the kidneys to the bladder.  It is difficult for surgeons to see the ureter during abdominal surgery.  This could lead to injuring the ureter which, although rare, could be serious.
ASP5354 is a potential new medical dye to help surgeons clearly see the ureter during surgery.  ASP5354 is injected into the body and is detected by a type of camera called near infrared fluoroscopy, or NIR-F for short.  Together they show live images of the ureter during surgery.  
Before ASP5354 is available as a medical dye, the researchers need to understand how it affects the body.  
In this study, the researchers will check how ASP5354 affects the body in adults up to 75 years old.  The main aim is to learn how ASP5354 is processed by the body in people whose kidneys do not work well compared to healthy people.  There will be 4 groups of people with different levels of how well their kidneys work.
This study will include a 3-night stay in a clinical research unit.  
People will be admitted to the clinic the day before they receive the ASP5354 injection.  The study doctor will take their medical history.  People will have an ECG to measure their heart rhythm, a medical examination, and will have their vital signs checked (pulse rate, body temperature and blood pressure).  They will also give blood and urine samples for laboratory tests.  For some women, this will include a pregnancy test.  People will need to fast for several hours before receiving the injection.  
The next day, people will receive 1 injection of ASP5354.  They will continue to fast for a few hours afterwards.  They will have an ECG and will have their vital signs checked.  They will also give blood and urine samples for laboratory tests and the study doctors will check for medical problems.
During the next 2 days, people will give more blood and urine samples and the study doctors will check for medical problems.  On the last day, people will also have their vital signs checked.  If there are no medical problems on the last day, people can return home.
People will return to the clinic about 1 week later for a final check-up.  They will have an ECG, a medical examination and have their vital signs checked.  They will give blood and urine samples for laboratory tests.  For some women, this will include a pregnancy test.  The study doctors will also check for medical problems.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Advanced Pharma CR, LLC

Orange County Research Center

Pinnacle Research Group

Sekino Clinical Pharmacology Clinic

P-One Clinic

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 in Participants with Renal Impairment Compared to Healthy Participants with Normal Renal Function

AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.

AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.

Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.

CL will be recorded from the pharmacokinetic (PK) plasma samples collected.

Aeinf will be recorded from the pharmacokinetic (PK) urine samples collected.

Aelast will be recorded from the pharmacokinetic (PK) urine samples collected.

Aeinf% will be recorded from the pharmacokinetic (PK) urine samples collected.

Aelast% will be recorded from the pharmacokinetic (PK) urine samples collected.

CLr will be recorded from the pharmacokinetic (PK) urine samples collected.

AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA).  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 

Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention.  This includes events related to the comparator and events related to the (study) procedures.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant ECG values.