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

NCT04878471 | Completed Phase 1

• 2 other identifiers: 5354-CL-0002jRCT2071210026
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

ASP5354; Pharmacokinetics

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 6 days

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

  Number of participants with potentially clinically significant laboratory values

  Up to 6 days

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

  Number of participants with potentially clinically significant vital sign values

  Up to 6 days

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

  Number of participants with potentially clinically significant ECG values

  Up to 6 days

Secondary Outcomes (6)

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

  Up to 2 days

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

  Up to 2 days

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

  Up to 2 days

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

  Up to 2 days

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

  Up to 2 days

Study Arms (2)

ASP5354

EXPERIMENTAL

Three participants in three dose levels will receive a single intravenous dose of ASP5354 on Day 1 under fasting conditions.

Drug: Pudexacianinium chloride

ASP5354 Matching Placebo

PLACEBO COMPARATOR

One participant in three dose levels will receive a single intravenous dose of matching placebo on Day 1 under fasting conditions.

Drug: Placebo

Interventions

Pudexacianinium chloride DRUG

Intravenous

Also known as: ASP5354

ASP5354

Placebo DRUG

Intravenous

ASP5354 Matching Placebo

Eligibility Criteria

• Age: 20 Years - 44 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (1)

JP81001

Sumida-ku, Tokyo, Japan

Location

Study Officials

• Medical Director

  Astellas Pharma Global Development, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 7, 2021
• Study Start: June 2, 2021
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: October 16, 2024

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)