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.
Participants were randomly assigned at each dose level (dose A, B, C). During a standard minimally invasive surgery, visualization of the surgical field was assessed following the placement of the near infrared fluorescence (NIR F) imaging system proximal to the ureter of interest and then ASP5354 was administered. Based on Visualization Review Committee (VRC) review of the initial 3 dose levels, if none of the doses selected had visualization, then additional two dose levels (dose D and E) was planned to be added; if 1 dose selected has visualization, then the dose level D was planned to be added. The dose level F was planned to be added if only the dose E level has visualization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
13
Intravenous
Center for Colon and Rectal Surgery; AdventHealth Medical Group
Orlando, Florida, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s)
The anatomical visualization of the index ureter(s) was assessed by the investigator intraoperatively using a binary "Yes or No" question on the ability to visualize the ureter and was assessed as successful, if both 30 minutes after pudexacianinium chloride dosing and at end of surgery the visualization was assessed as positive (Yes)/successful. For imputation of missing values at 30 minutes after pudexacianinium chloride administration, the nearest time points before and after the 30 minutes was considered. If both time points (before and after 30 minutes) were successful, 30 minutes anatomical visualization was imputed as successful. If both time points were not successful, then 30 minutes anatomical visualization was imputed as not successful, and all other cases were not imputed.
Time frame: 30 minutes postdose through end of surgery (on day 1)
Number of Participants With Treatment Emergent Adverse Events
An adverse event (AE) was any untoward medical occurrence in a participant administered an investigational product (IP), and which did not necessarily have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP. A TEAE was defined as an AE observed after administration of the IP and up to the follow-up period. An AE was considered "serious" if the event: results in death;is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions;results in congenital anomaly, or birth defect;requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization; Other medically important events.
Time frame: From first dose of study drug until follow-up period (day 10)
Plasma Concentration of Pudexacianinium Chloride
Plasma concentration of pudexacianinium chloride was reported from the blood samples collected. Concentrations below the lower limit of quantification (1 nanogram per milliliter \[ng/mL\]) are set to zero.
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Time frame: Predose, 10, 30, 60, 90, 120 minutes, end of surgery, 180 mins post dose
Urine Concentration of Pudexacianinium Chloride
Urine concentration of pudexacianinium chloride was reported from the urine samples collected. Concentrations below the lower limit of quantification (20 ng/mL) are set to zero.
Time frame: Predose, 10, 30, 60, 90 minutes, end of surgery, 180 mins post dose
Amount of Pudexacianinium Chloride Excreted in Urine (Ae) During Surgery
Amount of pudexacianinium chloride excreted in urine during surgery was reported.
Time frame: During surgery (on day 1)
Percentage of Pudexacianinium Chloride Dose Excreted Into Urine (Ae%) During Surgery
Percentage of pudexacianinium chloride dose excreted into urine during surgery was reported.
Time frame: During surgery (on day 1)