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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
12
Intravenous
Intravenous
JP81001
Sumida-ku, Tokyo, Japan
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 6 days
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
Time frame: 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)
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AUClast will be recorded from the PK plasma samples collected
Time frame: Up to 2 days
PK of ASP5354 in plasma: Maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected
Time frame: 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
Aelast will be recorded from the PK urine samples collected
Time frame: 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
Aelast% will be recorded from the PK urine samples collected
Time frame: Up to 2 days
PK of ASP5354 in urine: Renal Clearance (CLR)
CLR will be recorded from the PK urine samples collected
Time frame: Up to 2 days