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Healthy VolunteersPhase 1NCT04878471

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants

A Phase 1 study testing Pudexacianinium chloride in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants. Read more about this study

Who is it for?
Ages 20 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
Pudexacianinium chloride
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteJapan
Study dates
2 Jun 2021to 22 Jul 2021
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 20 to 44 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant has a body mass index (BMI) range of 17.6 to 26.4 kg/m^2 inclusive and weighs at least 50 kg at screening.
  • Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after Investigational Product (IP) administration.
  • Male participant must not donate sperm during the treatment period and for 30 days after IP 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 IP administration.
  • Participant agrees not to participate in another interventional study while participating in the present study.

Who cannot join

  • Participant has received any investigational therapy within 12 weeks prior to screening.
  • Participant has any condition that makes the participant unsuitable for study participation.
  • Participant has a known or suspected hypersensitivity to ASP5354 or any components of the formulation used.
  • 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]) above the upper limit of normal (ULN) on day -1. In such a case, the assessment may be repeated once.
  • Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
Show all 21Show 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 IP administration.
  • 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/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
  • Participant has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1.
  • Participant has a mean pulse < 40 or > 100 bpm; mean systolic blood pressure (SBP) < 90 or > 140 mmHg; mean diastolic blood pressure (DBP) < 40 or > 90 mmHg (measurements taken in triplicate after 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, one additional triplicate may be taken.
  • Participant has body temperature < 35.0ºC or >= 37.5ºC on day -1.
  • Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of > 430 msec on day -1. If the mean QTcF exceeds the limits above, one additional triplicate ECG may be taken.
  • Participant has used any prescribed or nonprescribed drugs (including vitamins, oral contraceptives or hormone replacement therapy (HRT) and natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to IP administration, except for occasional use of acetaminophen (up to 2 g/day) and topical dermatological products (including corticosteroid products).
  • Participant has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1.
  • Participant has a history of consuming > 16 units of alcohol per week within 3 months prior to day -1 (note: 1 unit = 10 g pure alcohol, = 250 mL of beer [5%], 35 mL of spirits [35%] or 100 mL of wine [12%]).
  • Participant has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or morphine and phencyclidines) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and morphine, phencyclidines) at screening or on day -1.
  • Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1.
  • 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.
  • Participant has a positive serology test for hepatitis B core (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and antigen or antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 and syphilis at screening.
  • Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • JP81001

    Sumida-ku, Tokyo

Other trials in Japan

About this study

Official title: A Phase 1 Single Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous doses of ASP5354 in healthy, adult Japanese male participants.

Read the detailed description

This study is comprised of 3 parts. Part 1 and Part 2 will be conducted in a parallel manner while Part 3 will be conducted subsequentially. Participants will be residential for a period of 3 days/2 nights. Participants will be discharged from the clinical unit on day 2 on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit.

Being tested
Pudexacianinium chloride, Placebo
Keywords
ASP5354; Pharmacokinetics

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

  • PlaceboDrug

    Intravenous

Study groups in NCT04878471
Study groupRoleWhat they receive
ASP5354ExperimentalThree participants in three dose levels will receive a single intravenous dose of ASP5354 on Day 1 under fasting conditions.
Receives: Drug: Pudexacianinium chloride
ASP5354 Matching PlaceboPlacebo comparatorOne participant in three dose levels will receive a single intravenous dose of matching placebo on Day 1 under fasting conditions.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study investigational product (IP), whether or not considered related to the study IP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or requires medical or surgical intervention to prevent one of the other outcomes listed above.

    Measured: Up to 6 days

  2. Number of participants with laboratory value abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant laboratory values

    Measured: Up to 6 days

  3. Number of participants with vital sign abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant vital sign values

    Measured: Up to 6 days

  4. Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or adverse events (AEs)

    Number of participants with potentially clinically significant ECG values

    Measured: Up to 6 days

Secondary outcomes (6)

  1. Pharmacokinetics (PK) of ASP5354 in plasma: Area under the concentration-time curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)

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

    Measured: Up to 2 days

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

    AUClast will be recorded from the PK plasma samples collected

    Measured: Up to 2 days

  3. PK of ASP5354 in plasma: Maximum concentration (Cmax)

    Cmax will be recorded from the PK plasma samples collected

    Measured: Up to 2 days

  4. PK of ASP5354 in urine: amount of administered dose excreted from the time of dosing to the last measurable point after dosing

    Aelast will be recorded from the PK urine samples collected

    Measured: Up to 2 days

  5. PK of ASP5354 in urine: percent of administered dose excreted from the time of dosing to the last measurable point after dosing

    Aelast% will be recorded from the PK urine samples collected

    Measured: Up to 2 days

  6. PK of ASP5354 in urine: Renal Clearance (CLR)

    CLR will be recorded from the PK urine samples collected

    Measured: Up to 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start2 Jun 2021
  3. Primary completion22 Jul 2021
  4. Study completion22 Jul 2021

Resources

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
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878471
Sponsor's protocol ID
5354-CL-0002
Other IDs
jRCT2071210026
Status last verified
Jun 2022
First submitted
6 May 2021
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
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/.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pudexacianinium chloride in people with Healthy Volunteers, run by Astellas Pharma Inc at 1 site in Japan.

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 5 inclusion and 21 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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. Some participants in this study may receive a placebo. 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?

Number of participants with Adverse Events (AEs) (time frame: Up to 6 days). The study lists 4 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 NCT04878471.

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 16 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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