Preventing iatrogenic ureteral damage preventing unneccessary damage to urinary tract
Conditions
Interventions
Nizaracianine or placebo
Sponsors
Curadel Surgical Innovations, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject is 18-55 years old at screening (inclusive). 2. Subject is able and willing to comply with study procedures. 3. Subject is in good general health, according to the investigator*s judgement based on vital signs, medical history, physical examination, and laboratory tests performed. 4. Body mass index between 18-32 kg/m2 (inclusive) and with a minimum body weight of 50 kg at screening. 5. An estimated GFR >= 90. 6. Female subjects need to be surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test at screening and before administration of nizaracianine. Pre-menopausal female subjects who are not surgically sterile have to agree to use an effective method of contraception. 7. Subject*s screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant. 8. Subject has negative test results for drug and alcohol screening. 9. Written informed consent must be given prior to any study activities, according to ICH/GCP and national/local regulations.
Exclusion criteria
Exclusion criteria: 1. (A history of) any clinically significant medical condition or abnormalities, as judged by the investigator, in physical examination, laboratory test results (including chemistry panel with hepatic and renal panels, complete blood count, and urine dipstick) or electrocardiography (ECG) at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated to confirm eligibility or judged by the investigator to be clinically irrelevant for healthy subjects. 2. Female subjects that are lactating or pregnant. 3. The subject has a positive screening test for hepatitis B, hepatitis C, and human immunodeficiency virus. 4. Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 7 days prior to study drug administrations, or less than five half-lives (whichever is longer, and during the course of the study). 5. Previous inclusion in this study. 6. Participation in a clinical trial within 3 months or 5 half-lives, whichever is longer. 7. Use of alcohol during the 24 hours prior to screening and/or an unwillingness to abstain from alcohol consumption during the stay at the clinical unit, and for at least 24 hours prior to each study visit; 8. Positive urine drug screen or alcohol test at screening and/or at first study day. 9. History of anaphylactic reactions to a prescription drug, over-the-counter drug, or herbal supplement. 10. Prior organ transplant. 11. Signs of moderate or severe symptoms of prostate hypertrophy 12. Loss or donation of blood over 500 mL within four months prior to screening. 13. Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject. 14. History of AV blocks or any type of AV block on the ECG at the screening 15. History of syncope
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Treatment-emergent (serious) adverse events ((S)AEs) throughout the study at every study visit • Concomitant medication throughout the study at every study visit • Vital signs (pulse rate (bpm), systolic blood pressure (mmHg), diastolic blood pressure (mmHg)) as per assessment schedule • Clinical laboratory tests (hematology, blood chemistry and urinalysis) as per assessment schedule • ECG parameters (heart rate (HR) (bpm), PR, QRS, QT, QTcF) as per assessment schedule | — |
Secondary
| Measure | Time frame |
|---|---|
| • PK- parameters of nizaracianine by multi-compartmental analysis of the plasma concentration-time data and urine data: * AUCinf, AUClast, CL/F, Cmax, t1/2, tlag, tmax, Vz/F * Dose-normalized PK parameters: AUCinf, AUClast, Cmax * Urine PK parameters: Aelast, Aelast%, CLR • Analysis of continuous NIR fluorescence imaging of the vascular flush in the abdominal vasculature from 5 seconds prior to the injection until 1 minute after the injection. PD-parameters are: * Fluorescent yes or no * Signal-to-background ratio (SBR) * Mean fluorescent intensity in the most prominent artery or vein * Mean fluorescent intensity in the background • Fluorescence intensity is reported as: * Fluorescent yes or no * Signal-to-background ratio (SBR) * Mean fluorescent intensity in the Foley tubing * Mean fluorescent intensity in the background | — |
Countries
Netherlands
Outcome results
None listed