The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ascending multiple oral doses of ASP3700 in healthy subjects.
Subjects will be confined in the clinic for 18 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Safety as assessed by adverse events
Time frame: up to end of study visit (up to 26 days)
Safety as assessed by vital signs
Time frame: up to end of study visit (up to 26 days)
Safety as assessed by orthostatic evaluation
Time frame: Days 1 and 14
Safety as assessed by laboratory tests
Laboratory tests include hematology, biochemistry and urinalysis.
Time frame: up to end of study visit (up to 26 days)
Safety profile: Routine 12-lead ECG, C-SSRS, ARCI-49, Bond and Lader VAS, continuous cardiac monitoring (12-lead Holter ECG), exploratory sex hormone-related and renal biomarkers
Electrocardiogram (ECG); Columbia-Suicide Severity Rating Scale (C-SSRS); Addiction Research Center Inventory(ARCI)-49 (49-item); Visual Analog Scale (VAS).
Time frame: up to end of study visit (up to 26 days)
Pharmacokinetics profile of ASP3700 (plasma): Cmax, tmax, tlag
Maximum concentration (Cmax); time of maximum concentration (tmax); time prior to the time corresponding to the first measurable (nonzero) concentration (tlag)
Time frame: Cmax, tmax = Days 1 and 14; tlag = Day 1
Pharmacokinetics profile of ASP3700 (plasma): AUCtau, CL/F, λz, MRT, t1/2, Vz/F, Rac (AUC), Rac (Cmax), PTR
Area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau); apparent oral clearance (CL/F); terminal elimination rate constant (λz); mean residence time (MRT); terminal elimination half-life (t1/2); apparent volume of distribution during terminal elimination phase after extravascular dosing (Vz/F); accumulation ratio based on AUE (Rac\[AUC\]); accumulation ratio based on Cmax (Rac\[Cmax\]); peak-trough ration (PTR)
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Time frame: Day 14
Pharmacokinetics parameter of ASP3700 (plasma): Ctrough
Concentration immediately prior to dosing at multiple dosing (Ctrough)
Time frame: Days 4, 6, 8, 10, 14 and 15
Pharmacokinetics profile of ASP3700 (urine): Ae24, Ae24%, Aetau, Aetau%
Cumulative amount of drug excreted in the urine from Time Zero to 24 hours (Ae24); percent fraction of administered drug excreted unchanged in the urine from time zero to 24 hours (Ae24%); cumulative amount of drug excreted in the urine over the dosing interval at steady-state (Aetau); percent fraction of administered drug excreted unchanged in the urine over the dosing interval at steady-state (Aetau%)
Time frame: Ae24, Ae24% = Day 1; Aetau, Aetau% = Day14
Pharmacokinetics parameter of ASP3700 (urine): CLR
Renal clearance (CLR)
Time frame: Days 1 and 14