A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well
Condition: Healthy Volunteers; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): pudexacianinium chloride
Intervention type(s): Drug
Intervention description(s): Intravenous
Other intervention name(s): ASP5354
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ASP5354; pudexacianinium chloride; Pharmacokinetics; Healthy Volunteers; Renal Impairment