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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis

NCT03282318

Bladder Pain Syndrome Interstitial Cystitis

COMPLETED PHASE2

Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

NCT01028014

Urethral Sphincter Activity

COMPLETED NA

The Use of Intranasal Ketoralac for Pain Management (Sprix)

NCT01736358

Postoperative Pain Management Urolithiasis

TERMINATED PHASE4

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

NCT03572231

Overactive Bladder (OAB)

COMPLETED

A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)

NCT02386072

Urinary Bladder Overactive Overactive Bladder Urinary Bladder Diseases +1 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Laparoscopic/Minimally Invasive Colorectal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pudexacianinium chloride - Dose Level A

Participants received single dose of pudexacianinium chloride at dose level A by intravenous (IV) bolus infusion on day 1 once the surgical area of interest is in view.

Group Type EXPERIMENTAL

Pudexacianinium chloride

Intervention Type DRUG

Intravenous

Pudexacianinium chloride - Dose Level B

Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.

Group Type EXPERIMENTAL

Pudexacianinium chloride

Intervention Type DRUG

Intravenous

Pudexacianinium chloride - Dose Level C

Participants received single dose of pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.

Group Type EXPERIMENTAL

Pudexacianinium chloride

Intervention Type DRUG

Intravenous

Pudexacianinium chloride - Dose Level B - Dose Expansion

Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.

Group Type EXPERIMENTAL

Pudexacianinium chloride

Intervention Type DRUG

Intravenous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pudexacianinium chloride

Intravenous

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ASP5354

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No