A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well

NCT05495581 | Completed Phase 1 FDA Drug

• 1 other identifier: 5354-CL-0004
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Healthy Volunteers; Renal Impairment

Keywords

ASP5354; pudexacianinium chloride; Pharmacokinetics; Healthy Volunteers; Renal Impairment

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetics (PK) of ASP5354 in plasma: area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)

  AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.

  Up to 3 days

• PK of ASP5354 in plasma: area under concentration-time curve from the time of dosing to the last measurable concentration (AUClast)

  AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.

  Up to 3 days

• PK of ASP5354 in plasma: maximum concentration (Cmax)

  Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.

  Up to 3 days

• PK of ASP5354 in plasma: apparent clearance (CL)

  CL will be recorded from the pharmacokinetic (PK) plasma samples collected.

  Up to 3 days

• PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to time infinity after single dose (Aeinf)

  Aeinf will be recorded from the pharmacokinetic (PK) urine samples collected.

  Up to 3 days

• PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to the last measurable amount (Aelast)

  Aelast will be recorded from the pharmacokinetic (PK) urine samples collected.

  Up to 3 days

• 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%)

  Aeinf% will be recorded from the pharmacokinetic (PK) urine samples collected.

  Up to 3 days

• 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%)

  Aelast% will be recorded from the pharmacokinetic (PK) urine samples collected.

  Up to 3 days

• PK of ASP5354 in urine: renal clearance (CLr)

  CLr will be recorded from the pharmacokinetic (PK) urine samples collected.

  Up to 3 days

Secondary Outcomes (4)

• Number of participants with Adverse Events (AEs)

  Up to 12 days

• Number of participants with laboratory value abnomalities and/or AEs

  Up to 12 days

• Number of participants with vital signs abnormalities and/or AEs

  Up to 12 days

• Number of participants with electrocardiogram (ECG) abnormalities and/or AEs

  Up to 12 days

Study Arms (4)

Mild renal impairment

EXPERIMENTAL

Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.

Drug: pudexacianinium chloride

Moderate renal impairment

EXPERIMENTAL

Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.

Drug: pudexacianinium chloride

Severe renal impairment

EXPERIMENTAL

Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.

Drug: pudexacianinium chloride

Normal renal function

EXPERIMENTAL

Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1.

Drug: pudexacianinium chloride

Interventions

pudexacianinium chloride DRUG

Intravenous

Also known as: ASP5354

Mild renal impairment; Moderate renal impairment; Normal renal function; Severe renal impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For US study sites:
• Participant has a body mass index (BMI) range of 18.5 to 40.0 kg/m\^2 inclusive and weighs at least 50 kg at screening.
• For Japan study sites:
• Participant has a BMI range of 17.6 to 30.0 kg/m\^2 inclusive and weighs at least 50 kg for male participants and 40 kg for female participants at screening.
• Female participant is not pregnant and at least 1 of the following conditions apply:
• Not a woman of child bearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after study intervention administration.
• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 30 days after study intervention administration.
• Female participant must not donate ova starting at study intervention administration and throughout the study period and for 30 days after study intervention administration.
• Male participant with female partner(s) of childbearing potential (including breastfeeding partner\[s\]) must agree to use contraception throughout the treatment period and for 30 days after study intervention administration.
• Male participant must not donate sperm during the treatment period and for 30 days after study intervention administration.
• Male participant 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 study intervention administration.
• Participant agrees not to participate in another interventional study while participating in the present study.
• Participant has normal renal function or participant has varying degrees of chronic kidney disease (CKD) as defined by the National Kidney Foundation and calculated by individual estimated glomerular filtration rate (eGFR) using the modification of diet in renal disease (MDRD) formula and individual body surface area (BSA):
• eGFR 60 to \< 90 mL/min for participants with mild renal impairment

You may not qualify if:

• Participant has received any investigational therapy within 28 days or 5 half-lives whichever is longer, prior to screening.
• Participant has any condition which makes the participant unsuitable for study participation.
• Participant has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Participant has had previous exposure with ASP5354.
• Participant has any of the liver function tests (alkaline phosphatase \[ALP\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and total bilirubin \[TBL\]) \>= 1.5 x upper limit of normal \[ULN\] on day -1. In such a case, the assessment may be repeated once.
• Participant has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to study intervention administration.
• Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
• Participant has a history of smoking \> 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1.
• For US study sites: Participant has a history of consuming \> 14 units for male participants or 7 units for female participants of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within 2 years prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
• For Japan study sties: Participant has a history of consuming \> 16 units of alcohol per week within 3 months prior to day -1 (note: 1 unit = 10 grams pure alcohol, 250 ml of beer \[5%\], 35 milliliters \[ml\] of spirits \[35%\] or 100 ml of wine \[12%\]) or the participant tests positive for alcohol at screening or on day -1.
• For Japan study sites: Participant has body temperature \< 35.0 degrees Celsius (C) or \>= 37.5 degrees C on day -1.
• Participant has used any moderate or strong inducers of Cytochrome P450 family 3 subfamily A (CYP3A) in the 3 months prior to day -1.
• For US study sites: Participant has had significant blood loss, donated \>= 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
• For Japan study sites: Participant has had significant blood loss, donated \>= 400 ml of whole blood within 90 days, \>= 200 ml of whole blood within 30 days or donated blood components within 14 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead

Study Sites (4)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33147, United States

Location

Sekino Clinical Pharmacology Clinic

Toshima-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 10, 2022
• Study Start: August 25, 2022
• Primary Completion: April 27, 2023
• Study Completion: May 8, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); JP (1)