The purpose of this study is to evaluate the safety and tolerability, and determine the blood levels (pharmacokinetics), in both a fed and fasted condition, of a single dose of ASN002. Healthy volunteers will be participants in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
22
Single dose study with food effect
InVentiv Health
Miami, Florida, United States
Number of subjects reporting adverse events during the study
Safety and tolerability will be determined by the number of subjects reporting adverse events during the study.
Time frame: Days 1-28
Area under the plasma concentration versus time curve (AUC)
Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours.
Time frame: Days 1-6
Area under the plasma concentration versus time curve (AUC) under fed and fasted conditions
Calculate Area under the plasma concentration time curve (AUC) from time 0 to infinity after first dose. AUC from time 0 to the time of last measured concentration. AUC from time 0 to 24 hours.
Time frame: Days 1-6
Maximum Plasma Concentration of ASN002
Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state.
Time frame: Days 1-6
Maximum Plasma Concentration of ASN002 under fed and fasted conditions
Calculate observed maximum plasma concentration after a dose and observed maximum plasma concentration at steady state. The time to reach the peak plasma concentration. The time to reach the peak plasma concentration at steady state.
Time frame: Days 1-6
Drug half life of ASN002
Calculate terminal elimination rate constant and terminal half-life of ASN002
Time frame: Days 1-6
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Drug half life of ASN002 under fed and fasted conditions
Calculate terminal elimination rate constant and terminal half-life of ASN002
Time frame: Days 1-6