A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

Completed · Phase 2

Conditions studied: Laparoscopic/Minimally Invasive Colorectal Surgery

In brief

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.

Key facts

Study ID

NCT04238481

Run by

Astellas Pharma Inc

People needed

13

Starts

2020-10-06

Expected to finish

2021-11-29

Last updated by the study team

2024-10-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Center for Colon and Rectal Surgery; AdventHealth Medical Group — Orlando, Florida, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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