The purpose of this study is to evaluate the safety and tolerability of single ascending oral doses of ASP1617 in healthy adult non-Asian and Japanese male and female participants. This study also evaluate the pharmacokinetics and determine the effect of food on the pharmacokinetics of a single oral dose of ASP1617.
After a screening period of up to 28 days prior to study drug administration, eligible participants will be residential for a single period of 8 days/7 nights in Part 1: single ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
97
California Clinical Trials Medical Group / Parexel
Glendale, California, United States
Number of participants with adverse events (AEs) in Part 1
An AE is any untoward medical occurrence in a subject administered an investigational product (IP) and which does not necessarily have to have a causal relationship with this treatment. 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 IP whether or not considered related to the IP. AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. An AE with onset at any time from first dosing until last scheduled procedure will be classified as a treatment-emergent adverse event (TEAE). A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator, or records where the relationship is missing.
Time frame: Up to Day 16
Number of participants with laboratory value abnormalities and/or AEs in Part 1
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 16
Number of participants with vital sign abnormalities and/or AEs in Part 1
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 16
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs in Part 1
Number of participants with potentially clinically significant 12-ECG values.
Time frame: Up to Day 16
Number of participants with AEs in Part 2
An AE is any untoward medical occurrence in a subject administered an IP and which does not necessarily have to have a causal relationship with this treatment. 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 IP whether or not considered related to the IP. AE is considered "serious" if the investigator or sponsor view any of the following outcomes: Death, life-threatening, persistent or significant disability/incapacity, congenital anomaly or birth defect, hospitalization, or medically important event. An AE with onset at any time from first dosing until last scheduled procedure will be classified as a TEAE. A drug-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator, or records where the relationship is missing.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to Day 29
Number of participants with laboratory value abnormalities and/or AEs in Part 2
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to Day 29
Number of participants with vital sign abnormalities and /or AEs in Part 2
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to Day 29
Number of participants with 12-ECG abnormalities and/or AEs in Part 2
Number of participants with potentially clinically significant 12-ECG values.
Time frame: Up to Day 29
Part 1: Pharmacokinetics (PK) of ASP1617 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 PK plasma samples collected.
Time frame: Up to Day 7
Part 1: PK of ASP1617 in plasma: AUC from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK plasma samples collected.
Time frame: Up to Day 7
Part 1: PK of ASP1617 in plasma: maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to Day 7
Part 2 (first dose): PK of ASP1617 in plasma: AUC from the time of dosing to 12 hours (AUC12)
AUC12 will be recorded from the PK plasma samples collected.
Time frame: Up to 12 hours
Part 2 (first dose and last dose): PK of ASP1617 in plasma: Cmax
Cmax will be recorded from the PK plasma samples collected.
Time frame: Up to Day 17
Part 2 (last dose): PK of ASP1617 in plasma: AUC during a dosing interval, where tau(τ) is the length of the dosing interval (AUCtau)
AUCtau will be recorded from the PK plasma samples collected.
Time frame: Up to Day 17
Part 2 (last dose): PK of ASP1617 in plasma: accumulation ratio calculated using AUC (Rac(AUC))
Rac(AUC) will be recorded from the PK plasma samples collected.
Time frame: Up to Day 17
PK of ASP1617 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Ctrough will be recorded from the PK plasma samples collected.
Time frame: Up to Day 17