Normal renal function for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pinnacle Research Group, Anniston, AL
Healthy Subjects (HS)+2 More
pudexacianinium chloride - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. ASP5354 is a potential new medical dye to help surgeons clearly see the ureter during surgery. ASP5354 is injected into the body and is detected by a type of camera called near infrared fluoroscopy, or NIR-F for short. Together they show live images of the ureter during surgery. Before ASP5354 is available as a medical dye, the researchers need to understand how it affects the body. In this study, the researchers will check how ASP5354 affects the body in adults up to 75 years old. The main aim is to learn how ASP5354 is processed by the body in people whose kidneys do not work well compared to healthy people. There will be 4 groups of people with different levels of how well their kidneys work. This study will include a 3-night stay in a clinical research unit. People will be admitted to the clinic the day before they receive the ASP5354 injection. The study doctor will take their medical history. People will have an ECG to measure their heart rhythm, a medical examination, and will have their vital signs checked (pulse rate, body temperature and blood pressure). They will also give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. People will need to fast for several hours before receiving the injection. The next day, people will receive 1 injection of ASP5354. They will continue to fast for a few hours afterwards. They will have an ECG and will have their vital signs checked. They will also give blood and urine samples for laboratory tests and the study doctors will check for medical problems. During the next 2 days, people will give more blood and urine samples and the study doctors will check for medical problems. On the last day, people will also have their vital signs checked. If there are no medical problems on the last day, people can return home. People will return to the clinic about 1 week later for a final check-up. They will have an ECG, a medical examination and have their vital signs checked. They will give blood and urine samples for laboratory tests. For some women, this will include a pregnancy test. The study doctors will also check for medical problems.

Eligible Conditions

  • Healthy Subjects (HS)
  • deteriorating renal function

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

9 Primary · 4 Secondary · Reporting Duration: Up to 12 days

Up to 12 days
Number of participants with Adverse Events (AEs)
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with laboratory value abnomalities and/or AEs
Number of participants with vital signs abnormalities and/or AEs
Up to 3 days
PK of ASP5354 in plasma: apparent clearance (CL)
PK of ASP5354 in plasma: area under concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
PK of ASP5354 in plasma: maximum concentration (Cmax)
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to the last measurable amount (Aelast)
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to the last measurable amount as a percentage of total cumulative amount of unchanged drug excreted in urine (Aelast%)
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to time infinity after single dose (Aeinf)
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to time infinity after single dose as a percentage of total cumulative amount of unchanged drug excreted in urine (Aeinf%)
PK of ASP5354 in urine: renal clearance (CLr)
Pharmacokinetics (PK) of ASP5354 in plasma: area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

4 Treatment Groups

Normal renal function
1 of 4
Moderate renal impairment
1 of 4
Severe renal impairment
1 of 4
Mild renal impairment
1 of 4
Experimental Treatment

36 Total Participants · 4 Treatment Groups

Primary Treatment: Normal renal function · No Placebo Group · Phase 1

Normal renal function
Drug
Experimental Group · 1 Intervention: pudexacianinium chloride · Intervention Types: Drug
Moderate renal impairment
Drug
Experimental Group · 1 Intervention: pudexacianinium chloride · Intervention Types: Drug
Severe renal impairment
Drug
Experimental Group · 1 Intervention: pudexacianinium chloride · Intervention Types: Drug
Mild renal impairment
Drug
Experimental Group · 1 Intervention: pudexacianinium chloride · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 days
Closest Location: Pinnacle Research Group · Anniston, AL
2003First Recorded Clinical Trial
2 TrialsResearching Healthy Subjects (HS)
36 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after study intervention administration.
You are male and have a female partner of childbearing potential
Male participant must not donate sperm during the treatment period and for 30 days after study intervention administration.
You agree not to participate in another interventional study while participating in the present study.
You are at least 50 kg in weight and have a BMI of at least 18.5 kg/m^2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.