A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
Condition: Laparoscopic/Minimally Invasive Colorectal Surgery
Intervention: Pudexacianinium chloride
Intervention description: Intravenous
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ASP5354; ureter visualization; imaging agent; near infrared fluorescence

Summary:

      The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter
      visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery
      This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in
      participants undergoing laparoscopic/minimally invasive colorectal surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.

          -  Subject will need visualization of the ureter(s).

          -  Female subject is not pregnant and at least 1 of the following conditions apply:

               -  Not a woman of childbearing potential (WOCBP)

               -  WOCBP who agrees to follow the contraceptive guidance from the time of informed
                  consent through at least 30 days after final study treatment administration.

          -  Female subject must agree not to breastfeed starting at screening and throughout the
             study period.

          -  Female subject must not donate ova starting at first dose of investigational product
             (IP) and throughout the study period and for 30 days after final study treatment
             administration.

          -  Male subject with female partner(s) of childbearing potential (including breastfeeding
             partner) must agree to use contraception throughout the treatment period and for 30
             days after final study treatment administration.

          -  Male subject must not donate sperm during the treatment period and for 30 days after
             final study treatment administration.

          -  Male subject with pregnant partner(s) must agree to remain abstinent or use a condom
             for the duration of the pregnancy throughout the study period and for 30 days after
             final study treatment administration.

          -  Subject agrees not to participate in another interventional study while participating
             in the present study.

          -  Subjects enrolled after optimal dose determination:

        Subject has any of the following values at screening:

          -  Body mass index > 25

          -  Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 60. Subjects
             with an eGFR ≥ 60 mL/min/1.73 m^2 may be considered after discussion with the medical
             monitor.

        Exclusion Criteria:

          -  Subject is anticipated to require ureteral stenting during surgery.

          -  Subject has a history of known retroperitoneal fibrosis.

          -  Subject has an active urinary tract infection.

          -  Subject has received any investigational therapy within 28 days or 5 half-lives,
             whichever is longer, prior to screening.

          -  Subject has any condition that makes the subject unsuitable for study participation.

          -  Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG)
             or any components of the formulation used.

          -  Subject has had previous exposure to ASP5354.

          -  Subject has moderate to severe cardiac disease that limits daily functioning (New York
             Heart Association Class III-IV) or other medical conditions that the investigator
             feels would impact safety or study compliance.

          -  Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood
             pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1.
             If the mean blood pressure exceeds the limits above, repeat readings can be taken.
             Subject who has adequately controlled blood pressure is eligible.

          -  Subject has a mean corrected QT interval (Triplicate electrocardiogram [ECG]) using
             Fridericia's formula (QTcF) > 430 msec (for male subjects) and > 450 msec (for female
             subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1
             additional triplicate ECG may be taken.

          -  Subject has any of the following screening laboratory values:

               -  Hemoglobin ≤ 9 g/dL

               -  Absolute neutrophil count ≤ 1500/µL

               -  Platelet count ≤ 100000/µL

               -  eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose
                  determination.)

               -  Serum bilirubin ≥ 2 × upper limit of normal (ULN)

               -  Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5
                  × ULN

               -  Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN

          -  Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents
             within 48 hours prior to study treatment administration.

          -  Subject has taken diuretics or inhibitors of renal transporters defined by Food and
             Drug Administration (FDA) within 48 hours prior to study treatment administration.

          -  Subject has used any illicit drugs, unless legally prescribed and is not being abused
             (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates)
             within 1 month prior to day -1.

          -  Subject has a history of alcohol abuse. Subject should not have consumed any alcohol
             within 48 hours of surgery.