A Phase 1 Single Intravenous Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASP5354 in Healthy Adult Japanese Male Participants
Overview
- Phase
- Phase 1
- Intervention
- Pudexacianinium chloride
- Conditions
- Healthy Volunteers
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse Events (AEs)
- Status
- Completed
- Last Updated
- last year
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 ASP
- •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 -
- •In such a case, the assessment may be repeated once.
- •Participant has creatinine level outside normal limits on day -
- •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.
Arms & Interventions
ASP5354
Three participants in three dose levels will receive a single intravenous dose of ASP5354 on Day 1 under fasting conditions.
Intervention: Pudexacianinium chloride
ASP5354 Matching Placebo
One participant in three dose levels will receive a single intravenous dose of matching placebo on Day 1 under fasting conditions.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with Adverse Events (AEs)
Time Frame: Up to 6 days
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.
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Time Frame: Up to 6 days
Number of participants with potentially clinically significant vital sign values
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Time Frame: Up to 6 days
Number of participants with potentially clinically significant laboratory values
Number of participants with routine 12-lead electrocardiogram (ECG) abnormalities and/or adverse events (AEs)
Time Frame: Up to 6 days
Number of participants with potentially clinically significant ECG values
Secondary Outcomes
- 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 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: Renal Clearance (CLR)(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)
- PK of ASP5354 in plasma: Maximum concentration (Cmax)(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)