This study is to assess the safety, tolerability, plasma concentration and pharmacodynamics of ASP7991 after single oral administration to healthy volunteers. In part-1, ASP7991 is administered in a dose escalation design. In part-2, plasma concentration changes of ASP7991 in fasted and fed conditions are compared.
This study consists of two parts. In Part 1, the study will begin as a single rising dose escalation design under randomized double-blind and fasting conditions. In each dose group, volunteers will be randomized to receive an oral administration of either active drug (ASP7991) or placebo. The dose escalation will be determined after blinded safety assessment. Part 2 is a study to evaluate the effect of food intake. ASP7991 will be administered to volunteers under 2 conditions, fasting and fed, on 2-way crossover method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
56
Unnamed facility
Kantou, Japan
The safety of ASP7991 assessed by the incidence of adverse events, vital signs, laboratory tests, 12-lead ECGs and Holter ECGs
Time frame: for 96 hours after dosing
Plasma Concentration of unchanged drug :Cmax, tmax, AUClast, AUCinf, t1/2, CL/F
Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours
Time frame: for 96 hours after dosing
Urinary concentrations of unchanged drug: Aelast,Aelast%, CLr
Urine samples are collected at the following times: redose and 0-4, 4-8, 8-12, 12-24, 24-36, 36-48, 48-72, 72-96 hours
Time frame: for 96 hour after dosing
plasma parathyroid hormon concentration
Blood samples are collected at the following times: redose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12,16, 24, 48, 72 and 96 hours
Time frame: for 96 hours after dosing
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