Healthy VolunteersPhase 1NCT05495581
A Study About How ASP5354 Affects the Body in Healthy Adults and in Adults Whose Kidneys do Not Work Well
A Phase 1 study testing pudexacianinium chloride in people with Healthy Volunteers and Renal Impairment, run by Astellas Pharma Global Development, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Renal Impairment
- What is being tested?
- pudexacianinium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Aug 2022to 8 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 19Show fewer
- 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
- eGFR 30 to < 60 mL/min for participants with moderate renal impairment
- eGFR < 30 mL/min without dialysis for participants with severe renal impairment, with approximately 50% of participants to have an eGFR of <= 20 mL/min
- eGFR >= 90 mL/min for participants with normal renal function
- Participant has adequate venous access.
Who cannot join
- 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.
Show all 45Show fewer
- 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.
- For US study sites: Participant has a positive serology test for hepatitis A Virus [HAV] antibodies (immunoglobulin M [IgM]), hepatitis B core [HBc] antibodies, hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] antibodies or antibodies to human immunodeficiency virus [HIV] type 1 and/or type 2 at screening.
- For Japan study sites: Participant has a positive serology test for HAV antibodies (IgM), HBc antibodies, HBsAg, HCV antibodies and/or antigen, antibodies to HIV type 1 and/or type 2 or syphilis at screening.
- Participant is an employee of Astellas, the study-related contract research organization (CRO) or the clinical unit.
- Participant has consumed grapefruit/Seville oranges or grapefruit/Seville orange-containing products within 72 hours prior to day -1.
- Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 2 weeks prior to study intervention administration or will have a COVID-19 vaccine dose before the end-of-study visit (ESV).
- Participant has a positive result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test at screening or on day -1.
- Additional criteria for participants with renal impairment:
- Participant has a history of any clinically significant illness (other than renal disease and conditions related to the renal disease, such as stable diabetes and stable hypertension), medical condition or laboratory abnormality within 3 months prior to screening which preclude the participant from study participation.
- For US study sites: Participant has a mean pulse < 40 or > 90 beats per minute (bpm); mean systolic blood pressure (SBP) < 90 or > 160 mmHg; mean diastolic blood pressure (DBP) < 50 or > 100 millimeters mercury [mmHg] (measurements taken in triplicate after the participant has been resting in a supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- For Japan study sites: Participant has a mean pulse < 40 or > 90 bpm; mean SBP < 90 or > 160 mmHg; mean DBP < 40 or > 90 mmHg (measurements taken in triplicate after the participant has been resting in a supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- For US study sites: Participant has a mean corrected QT interval by Fridericia (QTcF) of > 450 msec for male participants and > 480 msec for female participants on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate electrocardiogram (ECG) may be taken.
- For Japan study sites: Participant has a mean QTcF of > 450 msec for male participants and > 470 msec for female participants on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
- Participant who has had a change in dose regimen of medically required medication(s) in the 2 weeks prior to study intervention administration (permitted concomitant medications) and/or participant for whom dose changes are likely to occur during the study (minor dose changes are allowed in agreement with the sponsor) and/or participant has used nonpermitted concomitant medication(s) in the 3 weeks prior to admission to the clinical unit.
- Participant who requires or is likely to require any new concomitant medications during the course of the study.
- Participant who has a renal disease secondary to malignancy.
- Participant who has a fluctuating or rapidly deteriorating renal function within 4 weeks prior to study intervention administration, as indicated by strongly varying or worsening of clinical and/or laboratory signs of renal impairment within the screening period.
- Participant has a hemoglobin result of < 9 grams/deciliter (g/dL).
- Participant has a functioning kidney transplant.
- For US study sites: Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on day -1, unless the positive result is due to an approved prescription medication.
- For Japan study sites: Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or morphine, phencyclidines and tricyclic antidepressants) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or morphine, phencyclidines and tricyclic antidepressants) at screening or on day -1, unless the positive result is due to an approved prescription medication.
- Additional criteria for healthy participants with normal renal function:
- Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.
- Participant has any clinically significant abnormality following the physical examination, ECG and protocol-defined clinical laboratory tests at screening or on day -1.
- For US study sites: Participant has a mean pulse < 45 or > 90 bpm; mean SBP > 140 mmHg; mean DBP > 90 mmHg (measurements taken in triplicate after the participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- For Japan study sites: Participant has a mean pulse < 40 or > 100 bpm; mean SBP < 90 or > 140 mmHg; mean DBP < 40 or > 90 mmHg (measurements taken in triplicate after the participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
- Participant has a mean QTcF of > 450 msec for both male and female participants on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
- Participant has used any prescribed or nonprescribed drugs (including vitamins and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to study intervention administration, except for occasional use of acetaminophen (up to 2 grams/day), topical dermatological products (including corticosteroid products), hormonal contraceptives and hormone replacement therapy (HRT).
- Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
- For US study sites: Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) at screening or on day -1.
- For Japan study sites: Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or morphine, phencyclidines and tricyclic antidepressants) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or morphine, phencyclidines and tricyclic antidepressants) at screening or on day -1.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Advanced Pharma CR, LLC
Miami, Florida, 33147
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function
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.
Read more
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
- Being tested
- pudexacianinium chloride
- Keywords
- ASP5354, pudexacianinium chloride, Pharmacokinetics, Healthy Volunteers, Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pudexacianinium chlorideDrug
Also called ASP5354
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| Mild renal impairment | Experimental | Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. Receives: Drug: pudexacianinium chloride |
| Moderate renal impairment | Experimental | Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. Receives: Drug: pudexacianinium chloride |
| Severe renal impairment | Experimental | Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. Receives: Drug: pudexacianinium chloride |
| Normal renal function | Experimental | Participants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. Receives: Drug: pudexacianinium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 3 days
PK of ASP5354 in plasma: maximum concentration (Cmax)
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: Up to 3 days
PK of ASP5354 in plasma: apparent clearance (CL)
CL will be recorded from the pharmacokinetic (PK) plasma samples collected.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 3 days
PK of ASP5354 in urine: renal clearance (CLr)
CLr will be recorded from the pharmacokinetic (PK) urine samples collected.
Measured: Up to 3 days
Secondary outcomes (4)
Number of participants with Adverse Events (AEs)
AEs will be coded by Medical Dictionary for Regulatory Activities (MedDRA). An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator and events related to the (study) procedures.
Measured: Up to 12 days
Number of participants with laboratory value abnomalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Measured: Up to 12 days
Number of participants with vital signs abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Measured: Up to 12 days
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Measured: Up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start25 Aug 2022
- Primary completion27 Apr 2023
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495581
- Sponsor's protocol ID
- 5354-CL-0004
- Status last verified
- Nov 2024
- First submitted
- 9 Aug 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Publications
Kojima T, Saito M, Matsuda T, Simmons N, Nagata M, Miyagawa M, Wojtkowski T, Guro S, Koibuchi A, Cruz KS, Neutel JM, Free AL, Sekino H, Haas GP, Takusagawa S. Effects of renal impairment on the pharmacokinetics, safety, and tolerability of pudexacianinium (ASP5354) after IV administration: a mechanistic exploration. Eur J Clin Pharmacol. 2026 Apr 25;82(5):131. doi: 10.1007/s00228-026-04063-1.
PubMed 42032338
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ASP5354 in Participants With Renal Impairment Compared to Healthy Participants With Normal Renal Function
- ClinicalTrials.gov ID
- NCT05495581
- Acronym / sponsor ID
- 5354-CL-0004
- Conditions
- Healthy Volunteers, Renal Impairment
- Keywords
- ASP5354, pudexacianinium chloride, Pharmacokinetics, Healthy Volunteers, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mild renal impairment | Experimental | Drug: pudexacianinium chlorideParticipants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. |
| Moderate renal impairment | Experimental | Drug: pudexacianinium chlorideParticipants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. |
| Severe renal impairment | Experimental | Drug: pudexacianinium chlorideParticipants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. |
| Normal renal function | Experimental | Drug: pudexacianinium chlorideParticipants will receive a single intravenous dose of ASP5354 under fasting conditions on Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- 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:
- 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.
Key exclusion criteria (45 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pudexacianinium chlorideAlso: ASP5354Intravenous | Drug | Mild renal impairment, Moderate renal impairment, Normal renal function, Severe renal impairment |
Primary outcome
Pharmacokinetics (PK) of ASP5354 in plasma: area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf)
Time frame: Up to 3 days
AUCinf will be recorded from the pharmacokinetic (PK) plasma samples collected.
PK of ASP5354 in plasma: area under concentration-time curve from the time of dosing to the last measurable concentration (AUClast)
Time frame: Up to 3 days
AUClast will be recorded from the pharmacokinetic (PK) plasma samples collected.
PK of ASP5354 in plasma: maximum concentration (Cmax)
Time frame: Up to 3 days
Cmax will be recorded from the pharmacokinetic (PK) plasma samples collected.
PK of ASP5354 in plasma: apparent clearance (CL)
Time frame: Up to 3 days
CL will be recorded from the pharmacokinetic (PK) plasma samples collected.
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to time infinity after single dose (Aeinf)
Time frame: Up to 3 days
Aeinf will be recorded from the pharmacokinetic (PK) urine samples collected.
PK of ASP5354 in urine: cumulative amount of unchanged drug excreted in urine from time of dosing to the last measurable amount (Aelast)
Time frame: Up to 3 days
Aelast will be recorded from the pharmacokinetic (PK) urine samples collected.
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%)
Time frame: Up to 3 days
Aeinf% will be recorded from the pharmacokinetic (PK) urine samples collected.
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%)
Time frame: Up to 3 days
Aelast% will be recorded from the pharmacokinetic (PK) urine samples collected.
PK of ASP5354 in urine: renal clearance (CLr)
Time frame: Up to 3 days
CLr will be recorded from the pharmacokinetic (PK) urine samples collected.
4 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to 12 days
Number of participants with laboratory value abnomalities and/or AEs
Time frame: Up to 12 days
Number of participants with vital signs abnormalities and/or AEs
Time frame: Up to 12 days
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Time frame: Up to 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 42032338Kojima T, Saito M, Matsuda T, Simmons N, Nagata M, Miyagawa M, Wojtkowski T, Guro S, Koibuchi A, Cruz KS, Neutel JM, Free AL, Sekino H, Haas GP, Takusagawa S. Effects of renal impairment on the pharmacokinetics, safety, and tolerability of pudexacianinium (ASP5354) after IV administration: a mechanistic exploration. Eur J Clin Pharmacol. 2026 Apr 25;82(5):131. doi: 10.1007/s00228-026-04063-1.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pudexacianinium chloride in people with Healthy Volunteers and Renal Impairment, run by Astellas Pharma Global Development, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of ASP5354 in plasma: area under the concentration-time curve from time of dosing extrapolated to time infinity (AUCinf) (time frame: Up to 3 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05495581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.